MARGARITE ZINC CREAM- zinc cream cream

Margarite Zinc Cream by

Drug Labeling and Warnings

Margarite Zinc Cream by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Sulfur 4%

DO NOT USE

Do not use on

• broken skin
• large areas of the skin
• eyes and mouth

PURPOSE

Purpose

Acne Treatment

QUESTIONS

1.800.644.1466

STOP USE

If excessive skin irritation develops or increases, discontinue use and consult a doctor.

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

• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MARGARITE ZINC CREAM 
zinc cream cream

Product 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)