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 March 14, 2023
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PRINCIPAL DISPLAY PANEL - Kit Package
JOHNSON'S ®
welcome baby
gift set
set de regalo de bienvenida para bebéSAFETY TESTED
FOR DELICATE SKININCLUDES: 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)
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INGREDIENTS AND APPEARANCE
JOHNSONS WELCOME BABY GIFT SET
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0712 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0712-9 1 in 1 PACKAGE 07/01/2021 06/01/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 57 g Part 2 1 BOTTLE 400 mL Part 3 1 BOTTLE 400 mL Part 4 1 PACKET 25 Part 1 of 4 DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH
zinc oxide creamProduct Information Item Code (Source) NDC:69968-0603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 130 mg in 1 g Inactive Ingredients Ingredient Name Strength .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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0603-2 1 in 1 CARTON 1 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/01/2018 Part 2 of 4 JOHNSONS COTTONTOUCH NEWBORN WASH AND SHAMPOO
baby shampoos liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR PEG-80 SORBITAN LAURATE (UNII: 239B50Y732) INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y) INGR COTTON FIBER (UNII: 70LDW53ROO) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 400 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 07/09/2018 Part 3 of 4 JOHNSONS COTTONTOUCH NEWBORN FACE AND BODY
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COTTON FIBER (UNII: 70LDW53ROO) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CETEARYL OLIVATE (UNII: 58B69Q84JO) INGR SORBITAN OLIVATE (UNII: MDL271E3GR) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR TROPOLONE (UNII: 7L6DL16P1T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 400 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 07/09/2018 Part 4 of 4 JOHNSONS HAND AND FACE WIPES
cleansing (cold creams, cleansing lotions, liquids, and pads) clothProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR AMINO ACIDS, SILK (UNII: V0L00EX1IA) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 25 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 10/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/01/2021 06/01/2024 Labeler - Johnson & Johnson Consumer Inc. (118772437)