Active Ingredients
Dimethicone 1.5%
Claravie Skin Repair Cream
FDA Label NDC 61554-303
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 Skin Repair Cream (NDC 61554-303). 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 ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve chafed chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
Warnings
For external use only
When using this product
do not use near or get into the 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
Keep Out Of Reach Of Children
In case of accidental ingestion contact a physician or Poison Control Center right away.
Directions
Apply as needed
Other Information
Store between 59°F-86°F (15°C-30C)
Inactive Ingredients
Water, Propylene Glycol, Ceteary| Alcohol, Glycerin, Glyceryl Monostearate, Stearic Acid, PEG-100 Stearate, Carbomer, Olive Oil, Corn Oil, Canola Oil, Niacinamide, Alpha - Tocopherol Acetate, Vitamin A Palmitate, Cholecalciferol, Edetate Disodium, Aloe Vera Extract, Citrus Medica Limonum (Lemon) Peel Oil, Orange Oil, Lavender Oil, Sodium Hydroxide Ethylhexylglycerin, Phenoxyethanol, Pyridoxine HCI Fragrance, FD&C Blue No, 1, FD&C Red No. 40, FD&C Yellow No. 6
Dosage & Administration
Apply as needed.
Skin Repair Cream
Skin Repair Cream
* Please review the disclaimer below.
