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)
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)

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

PRINCIPAL DISPLAY PANEL - 454 g Jar Label

#1
CHOICE OF
PEDIATRICIANS & PARENTS

Desitin ®

Daily Defense
13% Zinc Oxide Diaper Rash Cream
relieves discomfort
in one application

protects against diaper
rash from the first use

free from parabens, phthalates, dyes and fragrance,
Hypoallergic • Pediatrician & Dermatologist tested

NET WT 1 lb
16 Oz (454 g)

PRINCIPAL DISPLAY PANEL - 454 g Jar Label

DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0603
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
TROPOLONE (UNII: 7L6DL16P1T)
.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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69968-0603-2	1 in 1 CARTON	12/01/2018
1		57 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:69968-0603-4	1 in 1 CARTON	12/01/2018
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:69968-0603-5	1 in 1 CARTON	12/01/2018
3		136 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:69968-0603-1	454 g in 1 JAR; Type 0: Not a Combination Product	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	12/01/2018

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream