OTC Medication Information: Aquaphor Healing Diaper Rash

AQUAPHOR HEALING DIAPER RASH- zinc oxide cream
Beiersdorf 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.

Zinc Oxide 15%

Skin Protectant

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

For external use only

When using this product • avoid contact with 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.

Inactive Ingredients

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

Magnesium Stearate, Panthenol, Water

Questions or comments

1-800-227-4703

Aquaphor Healing Cream

Baby

3 in 1

Diaper Rash Cream

Prevents Soothes Treats

Hypoallergenic

Cleans Off Easily

Paraben and Fragrance Free

15% Zinc Oxide Skin Protectant

Pediatrician Recommended Brand

AQUAPHOR HEALING DIAPER RASH zinc oxide cream

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

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

Inactive Ingredients Ingredient Name Strength MINERAL OIL CERESIN GLYCERIN PANTHENOL MAGNESIUM STEARATE WATER POLYGLYCERYL-4 ISOSTEARATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10356-105-10 99 g in 1 TUBE None 2 NDC:10356-105-23 10 g in 1 TUBE None 3 NDC:10356-105-02 7 g in 1 PACKET None 4 NDC:10356-105-29 4 g in 1 TUBE None

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)

Revised: 12/2022 Beiersdorf Inc