Aquaphor Healing Diaper Rash Cream
FDA Label NDC 10356-105

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 Diaper Rash (NDC 10356-105). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Zinc Oxide 15%

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

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

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

Magnesium Stearate, Panthenol, Water

Otc - Questions

Questions or comments

1-800-227-4703

* Please review the disclaimer below.