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

  • NDC Code(s): 69968-0061-1, 69968-0713-9
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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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
    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 DrugM01611/16/2015
    Part 2 of 3
    JOHNSONS HEAD TO TOE WASH 
    baby shampoos [baby products] 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 [baby products] 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 DrugM01607/02/2021
    Labeler - Kenvue Brands LLC (118772437)
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