Ammonium Lac 12% Cream 140gm
It is used to treat dry, scaly skin.It is used to treat itching caused by dry skin.
Drug Class
Keratolytic; Emollient; Moisturizer
Pharmacologic Class
Alpha-hydroxy acid (AHA)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream contains ammonium lactate, which is a natural moisturizer and exfoliant. It helps to soften and smooth rough, dry, or scaly skin by helping the skin shed dead cells and hold onto moisture.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to open wounds, cuts, or irritated skin.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs in your area.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to open wounds, cuts, or irritated skin.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs in your area.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, lips, and mucous membranes.
- Do not apply to irritated, inflamed, or broken skin.
- This product may increase your skin's sensitivity to the sun. Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week after stopping it.
- A mild stinging or burning sensation may occur, especially during the first few days of use. This usually subsides with continued use. If severe or persistent, discontinue use and consult a healthcare professional.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily
Condition-Specific Dosing:
xerosis:
Apply to dry, scaly skin areas twice daily
ichthyosis:
Apply to affected areas twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; generally, apply to affected areas twice daily if prescribed by a physician. Avoid use on very sensitive skin.
Adolescent:
Apply to affected areas twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Ammonium lactate (formed from lactic acid and ammonium hydroxide) is an alpha-hydroxy acid (AHA) that acts as a humectant, attracting and holding moisture in the skin. It also has keratolytic properties, promoting desquamation (shedding of dead skin cells) by interfering with corneocyte cohesion, leading to a smoother, softer skin surface. The ammonium hydroxide component primarily serves to neutralize the lactic acid to form ammonium lactate and adjust the pH of the formulation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5% of applied dose)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin texture and hydration
PeakEffect:
Weeks to months of consistent use
DurationOfAction:
Maintained with continued use; effects diminish upon discontinuation
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever)
- Respiratory issues, including wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking
- Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to monitor your response to the medication. If you notice any of the following side effects or any other unusual effects, contact your doctor for guidance:
- Irritation at the site of application
- Burning or stinging sensations
- Itching
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, consult your doctor. For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever)
- Respiratory issues, including wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking
- Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to monitor your response to the medication. If you notice any of the following side effects or any other unusual effects, contact your doctor for guidance:
- Irritation at the site of application
- Burning or stinging sensations
- Itching
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, consult your doctor. For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning
- Stinging that does not subside
- Excessive redness
- Swelling
- Blistering
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize potential side effects, avoid exposing the treated area to sunlight. Additionally, be aware that applying this drug after shaving or on sensitive, irritated, or broken skin may cause burning or stinging sensations.
If you use this medication on your face, you may have a higher risk of experiencing skin irritation. It is also important to use this drug as directed, as using it too frequently can worsen your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss the potential benefits and risks of this medication with your doctor, considering both your health and the baby's well-being.
To minimize potential side effects, avoid exposing the treated area to sunlight. Additionally, be aware that applying this drug after shaving or on sensitive, irritated, or broken skin may cause burning or stinging sensations.
If you use this medication on your face, you may have a higher risk of experiencing skin irritation. It is also important to use this drug as directed, as using it too frequently can worsen your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss the potential benefits and risks of this medication with your doctor, considering both your health and the baby's well-being.
Overdose Information
Overdose Symptoms:
- Severe local irritation
- Redness
- Burning
- Stinging
- Peeling
What to Do:
Wash the affected area thoroughly with water. Discontinue use. If irritation persists, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) immediately.
Drug Interactions
Minor Interactions
- Other topical exfoliants or irritants (e.g., retinoids, salicylic acid, benzoyl peroxide) - may increase irritation or dryness.
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, irritation)
Rationale: To assess baseline severity and guide treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, burning, stinging)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation; reduce frequency or discontinue use
Improvement in skin hydration and texture
Frequency: Weekly to monthly
Target: Reduced dryness, scaling, and roughness
Action Threshold: No improvement after several weeks of consistent use
Symptom Monitoring
- Skin redness
- Burning sensation
- Stinging sensation
- Itching
- Dryness or peeling (if excessive)
- Rash
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal, use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited data; minimal systemic absorption suggests low risk.
Second Trimester:
Limited data; minimal systemic absorption suggests low risk.
Third Trimester:
Limited data; minimal systemic absorption suggests low risk.
Lactation
L2 (Safer). Minimal systemic absorption makes it unlikely to be excreted in breast milk in clinically significant amounts. Use on breasts should be avoided to prevent infant ingestion.
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Use with caution in infants and young children due to potentially more sensitive skin and higher surface area to volume ratio. Not recommended for use in neonates or infants without specific medical advice. For older children, use under medical supervision if prescribed.
Geriatric Use
Generally safe for use in geriatric patients. Older adults may have thinner, more fragile skin, so monitor for increased irritation or sensitivity.
Clinical Information
Clinical Pearls
- Advise patients that a mild stinging or burning sensation is common upon initial application, especially on very dry or cracked skin, but it usually subsides.
- Emphasize the importance of consistent, twice-daily application for optimal results.
- Stress the need for sun protection (sunscreen, protective clothing) due to increased photosensitivity caused by AHAs.
- This product is often effective for conditions like xerosis, ichthyosis, and keratosis pilaris.
- Avoid applying to open wounds, cuts, or highly inflamed skin.
Alternative Therapies
- Urea cream (e.g., Ureacin, Keralac)
- Salicylic acid topical (for keratolytic effects)
- Alpha-hydroxy acid (AHA) products (other concentrations or types)
- Emollients and moisturizers (e.g., petrolatum, mineral oil, ceramides)
- Topical corticosteroids (for inflammatory skin conditions, not primary dryness)
Cost & Coverage
Average Cost:
$15 - $40 per 140gm tube
Generic Available:
Yes
Insurance Coverage:
Often OTC; prescription versions may be covered by some insurance plans (Tier 2-3), but many plans may not cover OTC products.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.