Label: JOHNSONS FIRST TOUCH BABY GIFT SET- zinc oxide kit

  • NDC Code(s): 69968-0603-2, 69968-0635-9
  • 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

    Drug Facts

  • Active ingredient

    Zinc Oxide 13%

  • 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 cream 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)
    • protect from freezing
    • may stain clothing
  • Inactive ingredients

    Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Extract, Glycerin, Tropolone, Tocopheryl Acetate, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide, Phenoxyethanol

  • Questions?

    Call toll-free 800-720-3843 or 215-273-8755 (collect) or visit www.desitin.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Tray Label

    Johnson's ®
    first touch
    baby gift set
    juego de regalo para bebés primeras caricias
    a selection of gentle products to cleanse, moisturize,
    and care for baby's delicate skin and hair

    no parabens, phthalates, sulfates or dyes

    Includes:

    DESITIN ® Daily Defense
    Zinc Oxide Diaper
    Rash Cream

    2 OZ (57g)

    1 recyclable
    storage caddy
    with handle

    Includes:
    JOHNSON'S ®
    baby shampoo

    6.8 FL OZ (200mL)

    JOHNSON'S ®
    HEAD-TO-TOE ®
    wash & shampoo

    10.2 FL OZ (300mL)

    JOHNSON'S ®
    baby lotion

    10.2 FL OZ (300mL)

    PRINCIPAL DISPLAY PANEL - Kit Tray Label
  • INGREDIENTS AND APPEARANCE
    JOHNSONS FIRST TOUCH BABY GIFT SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0635
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0635-91 in 1 TRAY05/01/202005/25/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 57 g
    Part 21 BOTTLE 200 mL
    Part 31 BOTTLE 300 mL
    Part 41 BOTTLE 300 mL
    Part 1 of 4
    DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:69968-0603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE130 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0603-21 in 1 CARTON
    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 finalpart34712/01/2018
    Part 2 of 4
    JOHNSONS BABY 
    baby shampoos shampoo
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    INGRLAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    INGRPEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRPEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1200 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 4
    JOHNSONS HEAD TO TOE WASH 
    baby shampoos shampoo
    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
    1300 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 4 of 4
    JOHNSONS BABY 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    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)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1300 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 finalpart34705/01/202005/25/2024
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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