Otc - Active Ingredient
Active Ingredient : Menthol 3%
Revalife
FDA Label NDC 42452-378
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by International Nutraceutical Company Of America (inca), Llc for the product Revalife (NDC 42452-378). 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 - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose-Topical Analgesic
Indications & Usage
Uses-Temporarily relieves minor pain of joints and muscles associated with arthritis, bursitis, tendonitis, strains
Dosage & Administration
Directions: Apply to clean, dry skin over painful joint or muscle gently massaging until cream disappears. For optimum results use daily for 30 days and continue to use daily thereafter. Repeat as neccessary. Close cap tightly after use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For external use only. Do not bandage tightly or use with a heating pad. Avoid contact with mouth, eyes, and mucous membranes. Do not apply to wounds, damaged, broken, or irritated skin.
Stop use and ask a doctor if: Symptoms persists over 7 day or clear up and occur again within a few days. Redness is present or irritation develops. Using on a child 12 years of age or under.
Inactive Ingredient
Inactive Ingredients: EDTA, Ethanol, Isopropyl palmitate, Methyl Paraben, Monosodium Phosphate, N-Acetyl Glucosamine, Poloxamer 407, Propyl Paraben, Soy Lecithin, Todopherol Acetate (Vitamin E), Water
Package Label.Principal Display Panel
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