Active Ingredient
Petrolatum 33%
Skin Protectant With 33% Petrolatum Cream
FDA Label NDC 87236-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Skin Protectant With 33% Petrolatum (NDC 87236-011). 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 active ingredient, purpose, use(s), warnings, stop use and ask a doctor if, do not use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Use(S)
• Temporarily protects and helps relieve dry, chapped, or cracked skin
• Helps protect skin from the drying effects of wind and cold weather
Warnings
For External Use Only
Do not get into eyes
Stop Use And Ask A Doctor If
- Conditions worsens
- Symptoms last more than 7 days or clear up and occur again within a few days
Do Not Use
• On deep puncture wounds • Animal bites • Serious burns.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Apply as needed
Other Information
• Store at room temperature 15°-30°C (59° - 86°F)
• Tamper evident. Do not use if seal is damaged.
Inactive Ingredients
DMDM Hydantoin, Lanolin Alcohol, Methyl Paraben, Mineral Oil, Paraffin, PEG 30 Dipolyhydroxystearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride
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