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 61554-311
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 61554-311). 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 (per gram), purpose, uses, warnings, do not use, when using this product, ask a doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (Per Gram)
Hydrocortisone Acetate USP (1% w/w)
Purpose
Anti-Itch
Uses
For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.
Warnings
For external use only
Do Not Use
- in the eyes
- for the treatment of diaper rash
- if you have vaginal discharge
- more than the recommended dosage
When Using This Product
- avoid contact with the eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Ask A Doctor Before Use
if you are pregnant or breastfeeding
Stop Use And Consult A Doctor If
- condition worsens
- if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- For itching of skin irritation, inflammation and rashes:
- For external anal and genital itching, adults:
- Adults and children over 2 years of age:
- apply evenly to affected area not more than 3 to 4 times daily
- children under 2 years of age:
- do not use, consult a doctor
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry, patting or blotting with bathroom tissue or soft cloth before applying
- apply externally to the area up to 6 times daily or after each bowel movement
- after application, discard pad
- do not flush in toilet
Dosage & Administration
For external anal and genital itching, adults:
when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
gently dry, patting or blotting with bathroom tissue or soft cloth before applying
apply externally to the area up to 6 times daily or after each bowel movement
Other Information
- Store at 66°F–77°F (20°C–25°C)
- Avoid excessive heat and humidity
Inactive Ingredients
Cetomacrogol 1000, Cetearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.
Hydrocortisone Anti-Itch Cream
Hydrocortisone Anti-Itch Cream Label:
* Please review the disclaimer below.
