Label: QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 63868-500-57
  • 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 December 16, 2022

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  • Active ingredient

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

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
  • Other information

    • store at 20°-25°C (68°-77°F)
    • may stain clothing
  • Inactive ingredients

    .alpha.-tocopherol acetate, butylated hydroxytoluene, lanolin, lavender oil, light mineral oil, methylparaben, petrolatum, polysorbate 60

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    C.D.M.A., INC.

    43157 W. NINE MILE

    NOVI, MI 48376

    www.qualitychoice.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    99197.1

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-500-571 in 1 CARTON11/11/2019
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/11/2019
    Labeler - Chain Drug Marketing Association Inc (011920774)
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