OTC Medication Information: Aquaphor Healing Fast Relief Diaper Rash

AQUAPHOR HEALING FAST RELIEF DIAPER RASH- zinc oxide ointment
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 40%

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

Glycerin, Caprylic/Capric Triglyceride,

Octyldodecanol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,

Magnesium Stearate, Panthenol,Butyrospermum Parkii (Shea) Butter, Water

Questions or comments

1-800-227-4703

Aquaphor Healing Paste

Baby

Fast Relief Diaper Rash Paste

Relieves Discomfort in 1 Use

Odor free

Hypoallergenic

Cleans off easily

Paraben and Talc Free

40% Zinc Oxide Skin Protectant

Maximum Strength Formula

AQUAPHOR HEALING FAST RELIEF DIAPER RASH zinc oxide ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-115 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 40 g in 100 g

Inactive Ingredients Ingredient Name Strength PANTHENOL MAGNESIUM STEARATE WATER OCTYLDODECANOL MEDIUM-CHAIN TRIGLYCERIDES POLYGLYCERYL-4 ISOSTEARATE SHEA BUTTER GLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10356-115-10 99 g in 1 TUBE None 2 NDC:10356-115-29 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 03/31/2017

Labeler — Beiersdorf Inc (001177906)

Revised: 12/2022 Beiersdorf Inc