Description
“Powered by nature, perfected by science—the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.”
Claravie Cream
FDA Label NDC 61554-312
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 61554-312). 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 description, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 12% w/w
Dimethicone 1% w/w
Purpose
Skin Protectant
Uses
- Helps prevent and protect protective undergarment rash.
- Protects minor skin irritation associated with protective undergarment rash and helps seal out wetness.
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
Keep Out Of Reach Of Children
In case of accidental ingestion, contact a physician or Poison Control Center right away.
Directions
- Change wet and soiled protective undergarments promptly.
- Cleanse the protective undergarment area, and allow to dry.
- Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged.
Other Information
- Store between 59°F–86°F (15°C–30°C)
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Chloroxylenol, Cholecalciferol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water
Dosage & Administration
Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged.
Otc - Questions
1-800-840-9041
- www.gentell.com
Advanced Barrier Cream
Advance barrier Cream Label:
* Please review the disclaimer below.
