JOHNSONS FIRST TOUCH BABY GIFT SET- zinc oxide
Johnson & Johnson Consumer Inc.

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.

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Johnsons first touch baby gift set

Desitin® Rapid Relief 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°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

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

PRINCIPAL DISPLAY PANEL - Kit Container

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:

JOHNSON'S®
baby shampoo
6.8 FL OZ (200 mL)

JOHNSON'S®
HEAD-TO-TOE®
wash & shampoo
10.2 FL OZ (300 mL)

JOHNSON'S®
baby lotion
10.2 FL OZ (300 mL)

Includes:

DESITIN® Rapid Relief
Zinc Oxide Diaper
Rash Cream
2 OZ (57 g)

1 recyclable
storage caddy
with handle

JOHNSONS FIRST TOUCH BABY GIFT SET
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0492

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0492-1	1 in 1 CONTAINER	06/01/2018	08/18/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	57 g
Part 2	1 BOTTLE, PUMP	300 mL
Part 3	1 BOTTLE	300 mL
Part 4	1 BOTTLE	200 mL

Part 1 of 4

DESITIN RAPID RELIEF DIAPER RASH
zinc oxide cream

Product Information
Item Code (Source)	NDC:69968-0219
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)
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)
Glycerin (UNII: PDC6A3C0OX)
Tropolone (UNII: 7L6DL16P1T)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)

#	Item Code	Package Description
Packaging
1	NDC:69968-0219-2	1 in 1 CARTON
1		57 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	10/20/2015

Part 2 of 4

JOHNSONS HEAD-TO-TOE WASH
baby shampoos shampoo

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Water (UNII: 059QF0KO0R)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	PEG-80 Sorbitan Laurate (UNII: 239B50Y732)
INGR	PEG-150 Pentaerythrityl Tetrastearate (UNII: 8L4OOQ76AM)
INGR	PPG-2 Hydroxyethyl Cocamide (UNII: 34N07GUJ3X)
INGR	Sodium methyl cocoyl taurate (UNII: JVL98CG53G)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Decyl Glucoside (UNII: Z17H97EA6Y)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
COSMETIC		06/15/2012

Part 3 of 4

JOHNSONS BABY
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Water (UNII: 059QF0KO0R)
INGR	Isopropyl palmitate (UNII: 8CRQ2TH63M)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Glyceryl monostearate (UNII: 230OU9XXE4)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Coconut Oil (UNII: Q9L0O73W7L)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Cetostearyl Alcohol (UNII: 2DMT128M1S)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	p-Anisic acid (UNII: 4SB6Y7DMM3)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Titanium Dioxide (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		300 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		06/15/2011

Part 4 of 4

JOHNSONS BABY
baby shampoos shampoo

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 Cocoyl Isethionate (UNII: 518XTE8493)
INGR	PEG-150 Distearate (UNII: 6F36Q0I0AC)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Decyl Glucoside (UNII: Z17H97EA6Y)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Lauryl Glucoside (UNII: 76LN7P7UCU)
INGR	Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		200 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		06/15/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/01/2018	08/18/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 8/2020

Document Id: 65ce7543-ed29-4a8b-969b-e0b4305f14c2

Set id: ce2e76ab-5f00-4d7f-ade1-f0b33d007671

Version: 2

Effective Time: 20200821

Johnson & Johnson Consumer Inc.