Otc - Active Ingredient
Lanolin 30%
Claravie Cream
FDA Label NDC 61554-301
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 61554-301). 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, otc - keep out of reach of children, warnings, otc - ask doctor, indications & usage, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, contact a physician or Poison Control Center right away.
Keep out of reach of children. In case of accidental ingestion, contact a physician or Poison control center right away.
Warnings
For external use only.
When using this product
do not get into eyes.
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
Do not use on
deep or puncture wounds
animal bites
serious burns
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
Indications & Usage
Uses
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.
Directions
Apply as needed
Otc - Questions
Dry Skin Protectant 5g_Sachet
Dosage & Administration
Apply as needed
Inactive Ingredient
Petrolatum, Mineral Oil, Water, Sorbiton Sesquioleate, Beeswax, Disodium EDTA, Lanolin Alcohol, Sodium Borate, Phenoxyethanol, Ethylglycerin
* Please review the disclaimer below.
