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

  • NDC Code(s): 58232-0723-3, 58232-9915-9
  • 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 30, 2023

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

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

    Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed in the US by:
    JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY
    Division of
    Johnson & Johnson Consumer Companies, Inc.
    Skillman, NJ 08558-9418

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Johnson's ®
    baby
    first touch ® gift set
    juego de regalo primer cuidado™

    Your Gift Contains:
    JOHNSON'S ® Baby Shampoo – 7 FL OZ (207 mL) ● JOHNSON'S ® Baby HEAD-TO-TOE ®
    Wash – 9 FL OZ (266 mL) ● JOHNSON'S ® Baby Lotion – 9 FL OZ (266 mL) ● DESITIN ®
    Rapid Relief Zinc Oxide Diaper Rash Cream – 2 OZ (56 g) ● 1 Bath Caddy

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    JOHNSONS BABY FIRST TOUCH GIFT SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-9915
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58232-9915-91 in 1 CONTAINER07/07/201512/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 56 g
    Part 21 BOTTLE 266 mL
    Part 31 BOTTLE 207 mL
    Part 41 BOTTLE 266 mL
    Part 1 of 4
    DESITIN RAPID RELIEF CREAMY FRAGRANCE FREE 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:58232-0723
    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)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58232-0723-31 in 1 CARTON
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/201312/01/2023
    Part 2 of 4
    JOHNSONS BABY 
    lotions, oils, powders, and creams
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1266 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/201212/01/2023
    Part 3 of 4
    JOHNSONS BABY 
    baby shampoos
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM TRIDECETH SULFATE (UNII: E827ILX331)  
    INGRPEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    INGRD&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1207 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/201112/01/2023
    Part 4 of 4
    JOHNSONS BABY HEAD-TO-TOE WASH 
    bath soaps and detergents
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRPEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    INGRSODIUM TRIDECETH SULFATE (UNII: E827ILX331)  
    INGRPEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1266 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/201212/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/07/201512/01/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)