Label: LIL GOATS ZINC OXIDE- zinc oxide ointment

  • 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 December 16, 2011

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  • ACTIVE INGREDIENT

    Zinc Oxide.......40.0%..........Skin Protectant

  • PURPOSE

    Use: Reduces underarm perspiration - Extra effective

  • PURPOSE

    Helps treat and prevent diaper rash

  • WARNINGS

    For External use only - When using this product avoid contact with eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • GENERAL PRECAUTIONS

    If swallowed, get medical help or contact a poison control center right away.

  • ASK DOCTOR

    Ask a doctor if condition worsens or does not improve within 7 days.

  • DOSAGE & ADMINISTRATION

    Directions change wet and soiled diapers promptly.  Clean the diaper area and allow to dry.  Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged..

  • INACTIVE INGREDIENT

    Petrolatum, Fresh goat's milk, mineral oil, emulsifying wax NF, parfum, beeswax, propylene glycol and diazolicinyl urea and methylparaben and propylparaben.

  • INDICATIONS & USAGE

    Skin Protectant

  • QUESTIONS

    www.canusgoatsmilk.com

  • HOW SUPPLIED

    Made in Canada for: Waitsfield, Vermont, United States, 05673 tel; 802-496-2527 and Ville St-Laurent, Québec, Canada H4R 1R7 tel: 514-738-8998

  • SPL UNCLASSIFIED SECTION

    Not tested on animals.

  • PRINCIPAL DISPLAY PANEL


    Zinc Oxide 40%

  • INGREDIENTS AND APPEARANCE
    LIL GOATS ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10100-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE113.6 g  in 284 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    APIS MELLIFERA (UNII: 7S82P3R43Z)  
    GOAT MILK (UNII: XE5K5I4RP7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10100-117-01284 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/16/2011
    Labeler - Canus Vermont LLC (102493025)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Emballages Knowlton Inc.248704645manufacture, analysis
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