Label: LIL GOATS ZINC OXIDE- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 February 6, 2013

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  • Active Ingredients:

    Petrolatum

    Zinc Oxide

  • Purpose:

    Skin Protectant.

  • Use:

    Helps treat and prevent diaper rash

  • WARNING:

    For external use only.

  • When using this product,

    avoid all contact with eyes.

  • Stop use and ask a doctor:

    if condition worsens or does not improve within 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • If swallowed:

    get medical help or contact the Poison Control Center immediately.

  • Directions:

    Apply oitment literally as often as necessary with each diaper change.

    Change wet and soiled diapers promptly.

    Clean the diaper area and allow to dry.

  • Store:

    at 20-25°C (68-77°F)

  • Inactive Ingredients:

    Caprae Lac, Meneral Oil, Emulsifying Wax NF, Beeswax, Parfum, Propylene Glycol, Dizolidinyl Urea, Methylparaben, Propylparaben.

  • Manufactured by:

    LEK Packaging Inc.

    Knowlton, Qc, Canada

    For:

    Canus Goats Milk Skin Care Products Inc.

    Les produits de soins pour la peru au lait de chèvre Canus inc.

  • Questions:

    Tel: (514)-738-8998, Ville St-Laurent, Qc, Canada

    Tel: (802) 244-4628, Waterbury USA, 05676

  • Other information:

    Not tested on animals.

  • 142g/5oz

    wrap label and CartonZOcdn5oz

  • INGREDIENTS AND APPEARANCE
    LIL GOATS ZINC OXIDE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10100-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 142 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM49.5 g  in 142 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP) 2.5 g  in 142 g
    GOAT MILK (UNII: XE5K5I4RP7) 5 g  in 142 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10100-119-021 in 1 CARTON
    1NDC:10100-119-01142 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2013
    Labeler - Canus Vermont LLC (102493025)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Emballages Knowlton Inc.248704645manufacture(10100-119) , analysis(10100-119)
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