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Margarite Zinc Cream

Dosage form: cream
Ingredients: SULFUR 1.12g in 28g
Labeler: Renu Laboratories, Inc.
NDC Code: 76348-413

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.

MARGARITE ZINC CREAM

Active ingredient

Sulfur 4%

Do not use on

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

Purpose

Acne Treatment

1.800.644.1466

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

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

For external use only

  • Keep out of the reach of children.

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.

Uses

  • treats acne
  • dries up acne pimples
  • helps prevent new acne pimples

MARGARITE ZINC CREAM 
zinc cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-413
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR1.12 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
WATER20.7 g  in 28 g
FERROUS OXIDE 
CETOSTEARYL ALCOHOL 
BENTONITE 
CASTOR OIL 
CANDELILLA WAX 
ZINC OXIDE 
POLYOXYL 20 CETOSTEARYL ETHER 
HYDROGENATED CASTOR OIL 
GLYCERYL MONOSTEARATE 
CETYL ALCOHOL 
PHENOXYETHANOL 
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76348-413-021 TUBE in 1 BOX
1NDC:76348-413-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/15/2013
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIOperations
Renu Laboratories, Inc.945739449manufacture(76348-413)

Revised: 09/2016
 
Renu Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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