Label: QUALITY CHOICE DIAPER RASH- zinc oxide ointment

  • NDC Code(s): 63868-948-04
  • Packager: Chain Drug Marketing Association Inc.
  • 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 May 23, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 40%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps protect skin from wetness
  • Keep out of the reach of children.

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

  • Warnings

    For External Use Only

    When using this product

    • Avoid contact with eyes

    This product contains trace amounts of naturally occuring lead.

  • 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.
  • Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again with a few days
  • Other Information:

    • Store at controlled room temperature 20° - 25°C (68° - 77°F)
  • Questions

    1-800-935-2362

  • Inactive Ingredients

    BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)

  • Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing

    Distributed by:

    C.D.M.A., Inc. ©

    43157 W 9 Mile Rd

    Novi, MI. 48375 USA

    www.qualitychoice.com

    Product of PRC

  • Other Information

    This product is not manufactured or distributed by Johnson & Johnson Consumer Company Inc. owner of the registered trademark Desitin®.

  • Packaging

    qc diaper rash

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-948
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LANOLIN (UNII: 7EV65EAW6H)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-948-04113 g in 1 TUBE; Type 0: Not a Combination Product12/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/19/2019
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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