Otc - Active Ingredient
Active ingredient
White petrolatum 100%
White Petrolatum Cream
FDA Label NDC 81417-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sled Distribution, Llc for the product White Petrolatum (NDC 81417-004). 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 - 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
Purpose
Skin protectant
Indications & Usage
Uses Temporarily protects minor cuts, scrapes, and burns. Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips. Helps prevent and protect from the drying effects of wind and cold weather.
Warnings
Warnings
For External use only
Otc - Do Not Use
Do not use on
- deep or puncture wounds
- animal bites
- or serious burns
Otc - When Using
When using this product do not get into 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 in 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.
Dosage & Administration
Directions apply as needed
Storage And Handling
Storage Store at room temperature. Avoid excessive heat.
Inactive Ingredient
water
Package Label.Principal Display Panel
Image Of Pouch Label (3)
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