Otc - Active Ingredient
White Petrolatum, 54%
Hydrolatum
FDA Label NDC 0295-9011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Denison Pharmaceuticals, Llc for the product Hydrolatum (NDC 0295-9011). 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, dosage & administration, other safety information, 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
- temporarily protects and helps relieve chapped or cracked skin
- helps prevent and protect from the drying effects of wind and cold weather
Warnings
- for external use only
- Keep out of reach of children
- Stop using if allergic
Otc - When Using
- do not get into eyes
- do not get into mouth
Otc - Stop Use
- if condition lasts more than 7 days
Dosage & Administration
- apply as needed
Other Safety Information
- Store at 20-25C (68-77F)
Inactive Ingredient
Methylparaben, Purified Water, Sorbitan Sesquioleate
Troubleshooting
Call Toll Free at 1-800-601-3843 or email [email protected]
Otc - Do Not Use
- deep or punctured wounds
- animal bites
- serious burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
* Please review the disclaimer below.
