Drug Facts
Menthol - 5% (External Analgesic)
Methyl Salicylate (NSAID) – 7.5% (External Analgesic)
Revalife Pain Relief Cream
FDA Label NDC 42452-379
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, Llc for the product Revalife Pain Relief Cream (NDC 42452-379). 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 drug facts, uses:, warnings:, otc - keep out of reach of children, otc - do not use, otc - ask doctor, otc - when using, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation
Warnings:
External Use Only!
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Do Not Use
Do not use:
• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area.
If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use
Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Otc - When Using
When using this product:
• avoid contact with eyes or mucous membranes
• do not bandage tightly
Indications & Usage
Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs
Directions:
Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
Children under 12 years of age: ask a doctor before use.
Inactive Ingredients:
Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Carbomer, Cetostearyl Alcohol, Coconut Oil, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexylglycerin, Glucosamine HCL, Glyceryl Monostearate, Hemp Oil, Magnesium Hydroxide, N-Acetyl Glucosamine, Phenoxyethanol, Polysorbate 80, Water
Other Information:
Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat
Allergy Alert:
Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.
For Questions
International Neutraceutical Company of America, LLC
1551 Dunwoody Village Parkway
P.O. Box 888882
Dunwoody, GA 30356 USA
+1 (404) 402-9354
www.revalife.com
Package Label.Principal Display Panel
Revalife Tube Label (Revalife.tube.label)
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