Label: JOHNSONS BABY CARE ESSENTIALS GIFT SET- zinc oxide kit

  • NDC Code(s): 69968-0061-1, 69968-0713-9
  • 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 4, 2023

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  • SPL UNCLASSIFIED SECTION

    DESITIN ® Maximum Strength Zinc Oxide Diaper Rash Paste

    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, Beeswax, Tocopheryl Acetate, Fragrance

  • Questions?

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

    For more information on preventing and treating diaper rash, visit www.desitin.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - Kit Package

    JOHNSON'S ®
    baby care essentials
    productos esenciales para el cuidado del bebé

    value
    pack

    all products are
    TSA compliant!

    Includes JOHNSON'S ® HEAD-TO TOE ® wash and shampoo 3.4 FL OZ (100 mL) ● JOHNSON'S ® baby lotion 3.4 FL OZ (100 mL)
    DESITIN ® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - Kit Package
  • INGREDIENTS AND APPEARANCE
    JOHNSONS BABY CARE ESSENTIALS GIFT SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0713
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0713-91 in 1 PACKAGE07/02/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 28 g
    Part 21 BOTTLE 100 mL
    Part 31 BOTTLE 100 mL
    Part 1 of 3
    DESITIN MAXIMUM STRENGTH DIAPER RASH  
    zinc oxide paste
    Product Information
    Item Code (Source)NDC:69968-0061
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0061-11 in 1 CARTON
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/16/2015
    Part 2 of 3
    JOHNSONS HEAD TO TOE WASH 
    baby shampoos liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRPEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    INGRPPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/09/2018
    Part 3 of 3
    JOHNSONS BABY 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/02/2021
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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