Otc - Active Ingredient
Lanolin 50%
Claravie Cream
FDA Label NDC 61554-307
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Claravie (NDC 61554-307). 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 - ask doctor, warnings, indications & usage, dosage & administration, inactive ingredient, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
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
Warnings
For external use only
Indications & Usage
Temporarily protects minor
- cuts
- scrapes
- burns
- Temporarily protects and helps relieve chafed, chapped or cracked skin
- Helps protect from the drying effects of wind and cold weather
Dosage & Administration
Apply as needed
Inactive Ingredient
Petrolatum, Mineral Oil, Water, Sorbitan Sesquioleate, Beeswax, Disodium EDTA, Lanolin Alcohol, Sodium Borate , Phenoxyethanol, Ethylhexylglycerin
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, contact a physician or Poison control center righy away.
Otc - Do Not Use
- Deep or puncture wounds
- animal bites
- serious burns
Otc - Purpose
Skin Protectant
* Please review the disclaimer below.
