Aquaphor Healing Ointment
FDA Label NDC 10356-101

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 (NDC 10356-101). 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 - do not use, 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

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Inactive Ingredient

→ Otc - Questions

→ Dosage & Administration

→ Package Label.principal Display Panel

Otc - Active Ingredient

Petrolatum 41%

Otc - Purpose

Skin Protectant Ointment

Treatment or Prevention of Diaper Rash

Indications & Usage

Uses

• temporarily protects minor: • cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked skin and lips
• helps protect from the drying effects of wind and cold weather

• helps treat and prevent diaper rash
• protects chafed skin associated with diaper rash and helps protect from wetness

Warnings

When using this product • do not get into eyes

Otc - Do Not Use

Do not use on

• deep or puncture wounds • animal bites
• serious burns

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

Mineral Oil, Ceresin, Lanolin Alcohol,
Panthenol, Glycerin, Bisabolol

Otc - Questions

Questions or comments?
1-800-227-4703

Dosage & Administration

Directions

• apply as needed

• for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.