Otc - Active Ingredient
Zinc Oxide 3.8% w/w
Claravie Cream
FDA Label NDC 61554-302
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 61554-302). 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 otc - active ingredient, otc - keep out of reach of children, otc - purpose, inactive ingredient, warnings, otc - ask doctor, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Otc - Purpose
Skin Protectant
Inactive Ingredient
Aloe Barbadendis Gel, Alpha Tocopherol, Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, DM Water, Glycerin, Lanolin, Lavendor, Mineral Oil, Parrafin, Phenoxyethanol, Propylene Glycol, Sodium Benzoate, Vitamin D , FD&C Yellow No.5, Microcrystalline Wax, Beeswax
Warnings
When using this product
- Do not get into eyes
Otc - Ask Doctor
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again in a few days
Indications & Usage
- Helps treat and prevent undergarment rash
- Temporarily protects minor cuts ,scrapes , burns , dries the oozing and weeping of poison ivy , poison oak , poison sumac
Dosage & Administration
Topical
Otc - Questions
Store at room temperature 59-86 0 F ( 15-30 0 C). Avoid excessive heat
* Please review the disclaimer below.
