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 61554-308
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 61554-308). 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, drug facts, uses, warnings, keep out of reach of children., direction, use in specific populations, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
| Active Ingredient | Purpose |
| Camphor 0.5% | External Analgesic |
Uses
For the temporary relief of pain and itching associated with:
- insect bites
- minor cuts
- minor burns
- sunburn
- scrapes
- minor skin irritations
- rashes due to poison ivy, poison oak, or poison sumac
Warnings
- For external use only.
When using this product avoid contact with eyes
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Keep Out Of Reach Of Children.
In case of accidental ingestion contact a physician or poison control center right away.
Direction
- Apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: do not use, consult a physician
Use In Specific Populations
- Adults and children 2 years of age and older:
Other Information
- Store between 59°F-86°F (15°C-30°C)
Inactive Ingredients
Carbomer, Cetostearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Imidurea, Glycol Stearate, Menthol, Mineral Oil, PEG-40 Castor Oil, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Cetostearyl Sulfate, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Water
Otc - Purpose
External Analgesic
Anti-Itch Cream
ClaraVie™
Anti-Itch Cream
Cools and Soothes with 0.5% Camphor
TREAT
Net Wt. 7.5 fl oz. | 222 mL
Package Label.Principal Display Panel
ClaraVie™
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