Johnsons Baby First Touch Gift Set (Zinc Oxide) Kit [Johnson & Johnson Consumer Inc.] -

JOHNSONS BABY FIRST TOUCH GIFT SET (ZINC OXIDE) KIT [JOHNSON & JOHNSON CONSUMER INC.]
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NDC	58232-0723-3, 58232-9915-9
Set ID	bee0ed35-a0ca-45d4-9fed-b890369e323e
Category	HUMAN OTC DRUG LABEL
Packager	Johnson & Johnson Consumer Inc.
Generic Name
Product Class
Product Number
Application Number	PART347

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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° 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

INGREDIENTS AND APPEARANCE

JOHNSONS BABY FIRST TOUCH GIFT SET
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-9915

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58232-9915-9	1 in 1 CONTAINER	07/07/2015	12/01/2023

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	56 g
Part 2	1 BOTTLE	266 mL
Part 3	1 BOTTLE	207 mL
Part 4	1 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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	130 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:58232-0723-3	1 in 1 CARTON
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/15/2013	12/01/2023

Part 2 of 4

JOHNSONS BABY
lotions, oils, powders, and creams

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	P-ANISIC ACID (UNII: 4SB6Y7DMM3)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		266 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/01/2012	12/01/2023

Part 3 of 4

JOHNSONS BABY
baby shampoos

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM TRIDECETH SULFATE (UNII: E827ILX331)
INGR	PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
INGR	D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		207 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/01/2011	12/01/2023

Part 4 of 4

JOHNSONS BABY HEAD-TO-TOE WASH
bath soaps and detergents

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
INGR	SODIUM TRIDECETH SULFATE (UNII: E827ILX331)
INGR	PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		266 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/01/2012	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/07/2015	12/01/2023

Labeler - Johnson & Johnson Consumer Inc. (002347102)

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Medic

JOHNSONS BABY FIRST TOUCH GIFT SET (ZINC OXIDE) KIT [JOHNSON & JOHNSON CONSUMER INC.]

When using this product

Stop use and ask a doctor if

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