WESTERN FAMILY DIAPER RASH (ZINC OXIDE) OINTMENT [TAI GUK PHARM. CO., LTD.]

WESTERN FAMILY DIAPER RASH (ZINC OXIDE) OINTMENT [TAI GUK PHARM. CO., LTD.]
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NDC 68169-0375-4
Set ID 2c0f0018-6389-4282-aa18-416b9329b8ca
Category HUMAN OTC DRUG LABEL
Packager TAI GUK PHARM. CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART347
  • 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
    • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
  • 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 vitamins A and D), fragrance, lanolin, light mineral oil, methylparaben, petrolatum, purified water, talc, tartrazine yellow #4 (FD and C yellow #4)

  • DOSAGE & ADMINISTRATION

    Proudly Distributed By:

    Western Family Foods, Inc.

    P.O. Box 4057, Portland, OR 97208 U.S.A.

    Copyright 2010 Marca Registrada

    www.westernfamily.com

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0375
    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)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-0375-41 in 1 CARTON
    156 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/05/2010
    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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