Label: ZINC OXIDE ointment

  • 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 November 14, 2022

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  • Active ingredient

    Zinc oxide 40%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to the 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
  • 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
    • 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 between 20⁰ and 25⁰C (68⁰ and 77⁰F)

  • Inactive ingredients

    petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

  • SPL UNCLASSIFIED SECTION

    *This product not manufactured or disturbed by Johnson & Johnson Consumer Products Company, distributor of Desitin Maximum Strength Diaper Rash Paste.

    DISTRIBUTED BY:

    RITE AID 

    30 HUNTER LANE

    CAMP HILL, PA 17011

    www.riteaid.com

    SATISFACTION GUARENTEE

    if you're not satisfied, we'll happily refund your money. 

  • principal display panel

    PARABEN FREE

    PHTHALATE FREE

    NDC 11822-0534-1

    MAXIMUM STRENGTH*

    DIAPER RASH PASTE

    40% ZINC OXIDE

    Specially formulated for effective diaper rash care in rich, thick formula

    Helps heal, soothe & prevent diaper rash

    Dye free

    *MAXIUMUM STRENGTH ZINC OXIDE DIAPER RASH OINTMENT AVAILABLE UNDER THE PRODOCT MONOGRAPH

    Compare to the ingredients in Destin Maximum Strength Original Ciaper Rash Paste*

    NET WT

    4OZ (113g)

    image description

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0534
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0534-11 in 1 PACKAGE08/24/2022
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/24/2022
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11822-0534)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11822-0534)
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