AQUAPHOR HEALING DIAPER RASH- zinc oxide cream

Aquaphor Healing Diaper Rash by

Drug Labeling and Warnings

Aquaphor Healing Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 15%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Uses
helps treat and prevent diaper rash
protects chafed skin associated with diaper rash and helps protect from wetness

Directions change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply ointment cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

WARNINGS

For external use only

WHEN USING

When using this product avoid contact with eyes

STOP USE

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

Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Inactive Ingredients

Mineral Oil, Glycerin, Ceresin, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,

Magnesium Stearate, Panthenol, Water

QUESTIONS

Questions or comments

1-800-227-4703

PRINCIPAL DISPLAY PANEL

Aquaphor Healing Baby

Diaper Rash Cream

3 in 1

Prevents Soothes Treats

Cleans Off Easily

Paraben and Fragrance Free

15% Zinc Oxide Skin Protectant

Pediatrician Recommended Brand

INGREDIENTS AND APPEARANCE

AQUAPHOR HEALING DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
MAGNESIUM STEARATE (UNII: 70097M6I30)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-105-10	99 g in 1 TUBE; Type 0: Not a Combination Product	01/30/2015
2	NDC: 10356-105-23	10 g in 1 TUBE; Type 0: Not a Combination Product	01/30/2015
3	NDC: 10356-105-02	7 g in 1 PACKET; Type 0: Not a Combination Product	01/30/2015
4	NDC: 10356-105-29	4 g in 1 TUBE; Type 0: Not a Combination Product	01/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/30/2015

Labeler - Beiersdorf Inc (001177906)