Label: JOHNSONS WELCOME BABY GIFT SET- zinc oxide kit

  • NDC Code(s): 69968-0603-2, 69968-0712-9
  • 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 April 12, 2022

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

  • SPL UNCLASSIFIED SECTION

    DESITIN ® Daily Defense Zinc Oxide Diaper Rash Cream

    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°F to 77°F)
    • 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)

    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 ®
    welcome baby
    gift set
    set de regalo de bienvenida para bebé

    SAFETY TESTED
    FOR DELICATE SKIN

    INCLUDES: JOHNSON'S ® COTTONTOUCH® NEWBORN WASH & SHAMPOO 13.6 FL OZ (400 mL) ● JOHNSON'S ®
    HAND & FACE WIPES 25 CT 7.5 × 7.3 IN (190 × 185 MM) ● JOHNSON'S ® COTTONTOUCH ® NEWBORN FACE &
    BODY LOTION 13.6 FL OZ (400 mL) ● DESITIN ® DAILY DEFENSE DIAPER RASH CREAM 2 OZ (57 G)

    Principal Display Panel - Kit Package
  • INGREDIENTS AND APPEARANCE
    JOHNSONS WELCOME BABY GIFT SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0712
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0712-91 in 1 PACKAGE07/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 57 g
    Part 21 BOTTLE 400 mL
    Part 31 BOTTLE 400 mL
    Part 41 PACKET 25 
    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
    .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)  
    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)  
    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 COTTONTOUCH NEWBORN WASH AND SHAMPOO 
    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)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRCOTTON FIBER (UNII: 70LDW53ROO)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRGLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRTETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1400 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 COTTONTOUCH NEWBORN FACE AND BODY 
    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)  
    INGRCOTTON FIBER (UNII: 70LDW53ROO)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRCETEARYL OLIVATE (UNII: 58B69Q84JO)  
    INGRSORBITAN OLIVATE (UNII: MDL271E3GR)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRTROPOLONE (UNII: 7L6DL16P1T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1400 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 HAND AND FACE WIPES 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cloth
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRAMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    125 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic10/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)