Label: ZINC OXIDE 20%- zinc oxide ointment

  • NDC Code(s): 63868-686-02
  • 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 20%

  • Purpose

    Skin Protectant

  • Uses

    • Protects skin
    • Protects and releives chafed skin due to diaper rash - helps seal out wetness
    • Dries the oozing and weeping of poison ivy, oak and sumac
  • 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
    • Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.
  • Directions

    • Apply ointment liberally as often as necessary
    • For the treatment of diaper rash, change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged
  • Other Information

    • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Inactive Ingredients

    Mineral Oil, Petrolatum

  • Distributed By:

    Distributed by CDMA Inc.

    43157 W 9 Mile Rd

    Novi, MI. 48375

    Product of PRC

    www.qualitychoice.com

    Questions: 800-935-2362

  • PRINCIPAL DISPLAY PANEL

    QC zinc oxide 2oz

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-686
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-686-021 in 1 BOX08/14/2020
    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 finalpart34708/14/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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