DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH- zinc oxide cream

Desitin Daily Defense Zinc Oxide Diaper Rash by

Drug Labeling and Warnings

Desitin Daily Defense Zinc Oxide Diaper Rash 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

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)

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

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 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)