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 Ointment
FDA Label NDC 61554-313
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 61554-313). 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 ingredients, 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 Ingredients
Dimethicone 5% w/w
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.
- Helps prevent and undergarment rash.
- Protects minor skin irritation associated with undergarment rash and helps seal out wetness.
Warnings
For external use only
When Using This Product
do not get in eyes.
Stop Use And Ask A Doctor If
- Condition worsens
- Symptoms last more than 7 days or clear 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.
Directions
As a skin protectant: Apply as needed
As an undergarment cream:
- Change wet and soiled undergarment promptly, because the undergarment area and allow to dry.
- Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged.
Other Information
- Store between 59°F-86°F (15°C-30°C)
Inactive Ingredients
Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Phenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, EDTA Disodium, Orange Oil, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, Alpha Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin
Otc - Questions
1-800-840-9041
• www.gentell.com
Dosage & Administration
- Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged.
Dimethicone Skin Protectant
Dimethicone Skin Protectant Label:
* Please review the disclaimer below.
