Label: DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH- zinc oxide paste

  • NDC Code(s): 69968-0396-1
  • Packager: Johnson & Johnson Consumer 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 January 6, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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 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 paste 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 20°C to 25°C (68°F to 77°F)
    • may stain clothing
  • Inactive ingredients

    petrolatum, cod liver oil, lanolin, talc, glycerin, sorbitan sesquioleate, penta erithrityl tetra-di-t-butyl hydroxyhydrocinnamite, beeswax, tocopheryl acetate, fragrance

  • Questions?

    Call toll-free 800-720-3843 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 454 g Jar Label

    #1 CHOICE OF PEDIATRICIANS
    & PARENTS

    Desitin ®
    Maximum Strength
    40% Zinc Oxide Diaper Rash Paste

    soothes and relieves on contact
    clinically proven, long-lasting relief

    Free from parabens, phthalates, and dyes
    Hypoallergenic . Pediatrician & Dermatologist tested

    • NET WT 1 lb
      16 Oz (454 g)
    Principal Display Panel - 454 g Jar Label
  • INGREDIENTS AND APPEARANCE
    DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0396
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0396-1454 g in 1 JAR; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2018
    Labeler - Johnson & Johnson Consumer Inc. (002347102)