Ammonium Lac 12% Lotion 227gm (otc)
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), Humectant
Pregnancy Category
Not available (Topical product, minimal systemic absorption expected)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This lotion contains lactic acid, which is a natural moisturizer that helps to soften and smooth rough, dry, and scaly skin. It works by helping your skin shed dead cells and draw in moisture, making your skin feel better.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
- Do not apply the medication to open wounds, cuts, or irritated skin.
- Shake the container well before each use.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it out of reach of children and pets. When you no longer need the medication or it has expired, dispose of it properly. Do not flush the medication down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available in your area.
Missing a Dose
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 continue with 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 safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
- Do not apply the medication to open wounds, cuts, or irritated skin.
- Shake the container well before each use.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it out of reach of children and pets. When you no longer need the medication or it has expired, dispose of it properly. Do not flush the medication down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available in your area.
Missing a Dose
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 continue with 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
- Apply to clean, dry skin.
- Avoid contact with eyes, lips, and mucous membranes.
- Do not apply to irritated, inflamed, or broken skin.
- Lactic acid can increase sun sensitivity. Use sunscreen and wear protective clothing when outdoors, even on cloudy days, while using this product and for at least a week after stopping use.
- Initial stinging or burning may occur, especially on very dry or cracked skin. This usually subsides with continued use.
Available Forms & Alternatives
Available Strengths:
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 areas twice daily.
ichthyosis:
Apply to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established (Consult physician)
Infant:
Not established (Consult physician, use with caution due to thinner skin)
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:
Not applicable (Minimal systemic absorption)
Moderate:
Not applicable (Minimal systemic absorption)
Severe:
Not applicable (Minimal systemic absorption)
Dialysis:
Not applicable (Minimal systemic absorption)
Hepatic Impairment:
Mild:
Not applicable (Minimal systemic absorption)
Moderate:
Not applicable (Minimal systemic absorption)
Severe:
Not applicable (Minimal systemic absorption)
Pharmacology
Mechanism of Action
Lactic acid is an alpha-hydroxy acid (AHA) that acts as a humectant, drawing moisture into the skin. It also has keratolytic properties, promoting the shedding of dead skin cells from the stratum corneum, which helps to soften and smooth rough, dry skin. Ammonium hydroxide is used to adjust the pH of the formulation, ensuring optimal activity and stability of lactic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 5% reported for topical lactic acid)
Tmax:
Not applicable (topical, local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (primarily local action, minimal systemic elimination)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin texture and hydration.
PeakEffect:
Several weeks of consistent use.
DurationOfAction:
Maintained with continued use.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 persist or bother you:
- Irritation at the site where the drug was applied
- Burning or stinging sensations
- 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 guidance. 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 attention 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 persist or bother you:
- Irritation at the site where the drug was applied
- Burning or stinging sensations
- 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 guidance. 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 or persistent stinging, burning, or itching
- Excessive redness or irritation
- Development of a rash or hives
- Swelling
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 as a result of the allergy.
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.
* 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 dosage 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 as a result of the allergy.
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.
* 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 dosage of any medication without first consulting your doctor.
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. 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 are more likely to experience skin irritation. Using this drug too frequently can worsen your skin condition. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation
- Redness
- Burning
- 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
Moderate Interactions
- Other topical exfoliants (e.g., salicylic acid, retinoids): May increase skin irritation or dryness.
Monitoring
Routine Monitoring
Skin irritation (redness, stinging, burning, itching)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: Discontinue use if severe or persistent irritation occurs.
Improvement in skin dryness/scaliness
Frequency: Weekly
Target: Smoother, more hydrated skin
Action Threshold: Consult physician if no improvement after 2-4 weeks.
Symptom Monitoring
- Skin redness
- Stinging or burning sensation (especially upon initial application)
- Itching
- Dryness or peeling (excessive)
- Rash
Special Patient Groups
Pregnancy
Generally considered low risk due to minimal systemic absorption. However, consult a healthcare professional before use.
Trimester-Specific Risks:
First Trimester:
Low risk, but consult physician.
Second Trimester:
Low risk, but consult physician.
Third Trimester:
Low risk, but consult physician.
Lactation
Generally considered low risk due to minimal systemic absorption. Avoid applying to areas where infants may ingest the product (e.g., breasts). Consult a healthcare professional before use.
Infant Risk:
Low risk (minimal systemic exposure to infant).
Pediatric Use
Use with caution, especially in infants and young children, as their skin is thinner and more sensitive, potentially leading to increased irritation. Consult a physician for use in children under 2 years of age.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments or precautions are typically required beyond general skin sensitivity considerations.
Clinical Information
Clinical Pearls
- Lactic acid can cause initial stinging or burning, especially on very dry or cracked skin. This is often temporary.
- Always advise patients about increased sun sensitivity and the importance of sunscreen.
- Not for use on open wounds, cuts, or severely inflamed skin.
- Consistent, daily use is key for optimal results in improving skin texture and hydration.
- Store at room temperature and keep out of reach of children.
Alternative Therapies
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory skin conditions, not for general dryness)
- Prescription strength lactic acid (e.g., Lac-Hydrin)
Cost & Coverage
Average Cost:
$15 - $30 per 227gm lotion
Generic Available:
Yes
Insurance Coverage:
Generally not covered by insurance as it is an OTC product, unless prescribed by a physician and covered under specific plans.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.