Otc - Active Ingredient
Zinc Oxide 40%
Aquaphor Healing Fast Relief Diaper Rash Ointment
FDA Label NDC 10356-115
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beiersdorf Inc for the product Aquaphor Healing Fast Relief Diaper Rash (NDC 10356-115). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Indications & Usage
Uses
• helps treat and prevent diaper rash
• protects chafed skin associated with diaper rash and helps protect from wetness
Dosage & Administration
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
Otc - When Using
When using this product • avoid contact with eyes
Otc - 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
Otc - 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
Glycerin, Caprylic/Capric Triglyceride,
Octyldodecanol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,
Magnesium Stearate, Panthenol,Butyrospermum Parkii (Shea) Butter, Water
Otc - Questions
Questions or comments
1-800-227-4703
Package Label.Principal Display Panel
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
Aquaphordiaperrashpastecarton (Aquaphordiaperrashpaste)
* Please review the disclaimer below.
