QC DIAPER RASH (ZINC OXIDE) CREAM [QUALITY HOME PRODUCTS]

QC DIAPER RASH (ZINC OXIDE) CREAM [QUALITY HOME PRODUCTS]
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NDC 64525-5382-2
Set ID 73e0606c-677c-46d0-9388-2f2f1ff0a39b
Category HUMAN OTC DRUG LABEL
Packager Quality Home Products
Generic Name
Product Class
Product Number
Application Number PART347
  • Active ingredient

    Zinc Oxide 10%

  • Purpose

    Skin Protectant

  • 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 lips
  • Warnings

    For external use only

    Do not use

    over deep or puncture wounds, infections or lacerations

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor

    if condition worsens or does not improve within 7 days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • Other information

    • store at room temperature
    • Lot No and Exp Date: see box or see crimp of tube
  • Inactive ingredients

    aloe vera gel, butylated hydroxytoluene, liquid paraffin, methyl parahydroxybenzoate, talc, tocopherol acetate, triethanolamine, purified lanolin, purified water, white petrolatum

  • Package label

    QC Diaper Rash Creamimage of product carton

  • INGREDIENTS AND APPEARANCE
    QC DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64525-5382
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.10 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TALC (UNII: 7SEV7J4R1U)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64525-5382-21 in 1 BOX
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/12/2011
    Labeler - Quality Home Products (205554157)

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