Ammonium Lac 12% Cream 140gm (otc)
It is used to treat dry, scaly skin.It is used to treat itching caused by dry skin.
Drug Class
Keratolytic, Emollient
Pharmacologic Class
Alpha-hydroxy acid (AHA)
Pregnancy Category
Category C (topical, minimal systemic absorption expected)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream helps to soften and moisturize very dry, rough, or scaly skin. It works by helping your skin shed dead cells and hold onto moisture, making it smoother and softer.
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 topically, directly to the affected skin area. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Precautions
Do not apply this medication to open wounds, cuts, or irritated skin.
Storage and Disposal
Store this medication at room temperature, away from heat and moisture.
Keep all medications in a safe and secure location, 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 Instructions
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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 topically, directly to the affected skin area. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Precautions
Do not apply this medication to open wounds, cuts, or irritated skin.
Storage and Disposal
Store this medication at room temperature, away from heat and moisture.
Keep all medications in a safe and secure location, 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 Instructions
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- For external use only. Avoid contact with eyes, lips, and mucous membranes.
- May cause stinging or burning, especially on broken or irritated skin. This usually lessens with continued use.
- Lactic acid can 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.
- Do not apply to acutely inflamed, oozing, or broken skin.
- Keep out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily or as directed by a physician.
Condition-Specific Dosing:
xerosis:
Apply to dry, scaly skin twice daily.
ichthyosis:
Apply to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, consult pediatrician)
Child:
Apply to affected areas twice daily or as directed by a physician (use with caution, may cause irritation)
Adolescent:
Apply to affected areas twice daily or as directed by a physician
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
Lactic acid is an alpha-hydroxy acid (AHA) that acts as a humectant, attracting and holding moisture in the skin. It also has keratolytic properties, promoting the shedding of dead skin cells and softening hyperkeratotic areas by interfering with corneocyte cohesion. Ammonium hydroxide is used to adjust the pH of the cream to optimize the activity of lactic acid and enhance its penetration.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (for topical application)
Tmax:
Not well characterized for topical use
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:
Dependent on continued application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- 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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Irritation at the site where the drug was applied
- Burning or stinging sensation
- Itching
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- 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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Irritation at the site where the drug was applied
- Burning or stinging sensation
- Itching
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for medical advice. 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, itching, or redness that does not subside.
- Signs of an allergic reaction (e.g., rash, hives, swelling, difficulty breathing).
- Worsening of skin condition.
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 symptoms you experienced.
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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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 symptoms you experienced.
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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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 be at a higher risk of experiencing skin irritation. It is also important to use this drug as directed, as excessive use can worsen your skin condition.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
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 be at a higher risk of experiencing skin irritation. It is also important to use this drug as directed, as excessive use can worsen your skin condition.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic effects.
- Excessive local irritation, redness, burning, or peeling.
What to Do:
Wash the affected area thoroughly with water. If irritation persists, discontinue use and consult a healthcare professional. For accidental ingestion, call a Poison Control Center (1-800-222-1222) immediately.
Drug Interactions
Moderate Interactions
- Other topical exfoliants or irritants (e.g., retinoids, salicylic acid, benzoyl peroxide): May increase skin irritation, dryness, or peeling.
Monitoring
Routine Monitoring
Skin condition (redness, irritation, dryness)
Frequency: Daily, with each application
Target: Improvement in dryness/scaling, minimal irritation
Action Threshold: Persistent or severe stinging, burning, redness, or itching; discontinue use and consult physician.
Symptom Monitoring
- Stinging or burning sensation upon application (especially initially)
- Redness or erythema
- Itching
- Dryness or peeling (may indicate excessive use or sensitivity)
- Signs of allergic reaction (rash, swelling, severe itching)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, use only if clearly needed and under medical advice.
Trimester-Specific Risks:
First Trimester:
Low risk, but caution advised.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Minimal systemic absorption makes it unlikely to pose a significant risk to a nursing infant. Avoid applying to areas where the infant may ingest the cream (e.g., breasts).
Infant Risk:
Low risk (L3 - Limited data â probably compatible, but caution advised).
Pediatric Use
Can be used in children, but with caution as their skin may be more sensitive and prone to irritation. Consult a pediatrician for use in infants or very young children. Avoid use on large body surface areas or broken skin.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically needed. Older adults may have thinner, more fragile skin, so monitor for increased irritation.
Clinical Information
Clinical Pearls
- Initial stinging or burning is common, especially on very dry or cracked skin, and usually subsides with continued use.
- Always apply sunscreen daily when using this product, as lactic acid increases sun sensitivity.
- For best results, apply after bathing while skin is still damp to lock in moisture.
- Consistency is key; regular use is necessary to maintain skin hydration and smoothness.
- If severe irritation occurs, reduce frequency of application or discontinue use and consult a healthcare provider.
Alternative Therapies
- Emollients (e.g., petroleum jelly, mineral oil, dimethicone-based creams)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory skin conditions, not for dryness alone)
- Prescription keratolytics (e.g., higher concentration urea, tazarotene)
Cost & Coverage
Average Cost:
$15 - $30 per 140gm tube
Generic Available:
Yes
Insurance Coverage:
OTC (Over-The-Counter), generally not covered by insurance unless prescribed by a physician and deemed medically necessary.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.