Otc - Active Ingredient
Active ingredient
Sulfur 4%
Margarite Zinc Cream
FDA Label NDC 76348-413
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Margarite Zinc Cream (NDC 76348-413). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - do not use, otc - purpose, otc - questions, otc - stop use, otc - when using, warnings, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Do Not Use
Do not use on
- broken skin
- large areas of the skin
- eyes and mouth
Otc - Purpose
Purpose
Acne Treatment
Otc - Questions
1.800.644.1466
Otc - Stop Use
If excessive skin irritation develops or increases, discontinue use and consult a doctor.
Otc - When Using
When Using this Product
- apply only to areas with acne
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
- If irritation occurs, only use one topical acne medication at a time.
Warnings
Warnings
For external use only
Otc - Keep Out Of Reach Of Children
- Keep out of the reach of children.
Inactive Ingredient
Inactive Ingredients:
Water, Zinc Oxide (10%), Cetearyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Cetyl Alcohol, Glyceryl Stearate, Titanium Dioxide, Vegetable Oil (Castor), Hydrogenated Vegetable Oil (Castor), Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Bentonite, Phenoxyethanol, Iron Oxides.
Directions
- Cleanse the skin thoroughly before applying ZINC CREAM FOR PROBLEM SKIN.
- Cover the entire affected area up to three times daily
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day. ZINC CREAM FOR PROBLEM SKIN can be used under make-up or moisturizer.
Indications & Usage
Uses
- treats acne
- dries up acne pimples
- helps prevent new acne pimples
Package Label.Principal Display Panel
* Please review the disclaimer below.
