JOHNSONS FIRST TOUCH BABY GIFT SET- zinc oxide kit

Johnsons first touch baby Gift Set by

Drug Labeling and Warnings

Johnsons first touch baby Gift Set by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Desitin® Rapid Relief zinc oxide diaper rash cream

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°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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

JOHNSONS FIRST TOUCH BABY GIFT SET 
zinc oxide kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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
Water (UNII: 059QF0KO0R)
Mineral Oil (UNII: T5L8T28FGP)
Petrolatum (UNII: 4T6H12BN9U)
Yellow wax (UNII: 2ZA36H0S2V)
Dimethicone (UNII: 92RU3N3Y1O)
Sorbitan (UNII: 6O92ICV9RU)
Microcrystalline Wax (UNII: XOF597Q3KY)
PEG-30 Dipolyhydroxystearate (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0219-2	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	10/20/2015

Part 2 of 4

JOHNSONS HEAD-TO-TOE WASH 
baby shampoos shampoo

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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

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

Part 3 of 4

JOHNSONS BABY 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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	Carboxypolymethylene (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)

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

Part 4 of 4

JOHNSONS BABY 
baby shampoos shampoo

Product 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	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)

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

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

Labeler - Johnson & Johnson Consumer Inc. (002347102)