Label: MARGARITE ZINC CREAM- zinc cream cream
- NDC Code(s): 76348-413-01, 76348-413-02
- Packager: Renu Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 14, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DO NOT USE
- PURPOSE
- QUESTIONS
- STOP USE
- WHEN USING
- WARNINGS
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MARGARITE ZINC CREAM
zinc cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-413 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 1.12 g in 28 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 20.7 g in 28 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) CASTOR OIL (UNII: D5340Y2I9G) CANDELILLA WAX (UNII: WL0328HX19) ZINC OXIDE (UNII: SOI2LOH54Z) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-413-02 1 in 1 BOX 10/13/2015 1 NDC:76348-413-01 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/13/2015 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-413)
