Label: PREMIER VALUE DIAPER RASH- zinc oxide ointment

  • 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 September 30, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                     Purpose

    Zinc oxide, 40% .....................................................................Skin protectant

  • PURPOSE

    Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect skin from wetness
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    over deep or puncture wounds, infections or lacerations

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    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 a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • change wet and soiled diapers promptly, cleanse 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
  • STORAGE AND HANDLING

    Other information

    • store at 20o to 25oC (68o to 77oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    BHA, cod liver oil (high in vitamin A and D), fragrance, lanolin, methylparaben, petrolatum, talc and purified water, light mineral oil, tartrazine yellow #4 (FD and C yellow #4)

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Chain Drug Consortium, LLC.

    3301 N.W. Boca Raton Blvd., Suite 101

    Boca Raton, FL 33431

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.40 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-0128-21 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/30/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture
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