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

Fast Relief Diaper Rash Paste

Relieves Discomfort in 1 Use

No Odor

Cleans off easily

Hypoallergenic

Paraben and Talc Free

40% Zinc Oxide Skin Protectant

Maximum Strength Formula

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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
GLYCERIN
PANTHENOL
MAGNESIUM STEARATE
WATER
OCTYLDODECANOL
MEDIUM-CHAIN TRIGLYCERIDES
POLYGLYCERYL-4 ISOSTEARATE
SHEA BUTTER
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: 12/2021 Beiersdorf Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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