Label: GRAHAMS NATURAL DIAPER RASH- zinc oxide cream

  • 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 August 30, 2016

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Zinc Oxide 12%

  • PURPOSE

    PURPOSE

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Uses and Indications

    For the relief of diaper rash, minor cuts and burns

  • DOSAGE & ADMINISTRATION

    Directions

    Apply cream, liberally, and as often as necessary to dry skin, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • WARNINGS

    Warnings 

    For external use only

    Avoider contact with eyes. If any adverse reaction develops, stop use, and contact a physician.

  • QUESTIONS

    

    Questions 

    www.itchy.net.au

    Made in Australia

    Grahams Natural Alternatives Pty Ltd

    7 Palings Crt, Nerang, QLD 4211 Australia

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Betaine,
    Glycerin, Cetearyl Alcohol, Glyceryl Stearate SE, Coco-
    Caprylate, Prunus Amygdalus Dulcis (Sweet Almond) Oil),
    Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum
    Parkii (Shea Butter), Beeswax, Caprylic/Capric
    Triglyceride, Sodium Stearoyl Glutamate, Jojoba Oil,
    Xanthan Gum, Chamomile Extract, Calendula Extract,
    Tocopherol Acetate, Phenoxyethanol, Capryl Glycol

  • PRINCIPAL DISPLAY PANEL

    back labelFront Label

  • INGREDIENTS AND APPEARANCE
    GRAHAMS NATURAL DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALENDULA ARVENSIS LEAF (UNII: 3U3U118F2L)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42387-135-0173 g in 1 TUBE; Type 0: Not a Combination Product07/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/21/2016
    Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grahams Natural Alternatives Pty Ltd742235419manufacture(42387-135)
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