MARGARITE ZINC CREAM (ZINC CREAM) CREAM [RENU LABORATORIES, INC.]

MARGARITE ZINC CREAM (ZINC CREAM) CREAM [RENU LABORATORIES, INC.]
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NDC 76348-413-01, 76348-413-02
Set ID 3ca3b7d8-702a-036b-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Renu Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
  • 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

    zinc cream tubebox art for zinc cream

  • INGREDIENTS AND APPEARANCE
    MARGARITE ZINC CREAM 
    zinc cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1.12 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-413-021 in 1 BOX10/13/2015
    1NDC:76348-413-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/13/2015
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-413)

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