Revalife Pain Relief Cream: Package Insert and Label Information

REVALIFE PAIN RELIEF CREAM- menthol and methyl salicylate cream
International Nutraceutical Company of America, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Menthol — 5% (External Analgesic)
Methyl Salicylate (NSAID) – 7.5% (External Analgesic)

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!

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use:
• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

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.

When using this product:
• avoid contact with eyes or mucous membranes
• do not bandage tightly

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

REVALIFE PAIN RELIEF CREAM menthol, methyl salicylate cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42452-379 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.05 kg in 1 kg METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.075 kg in 1 kg

Inactive Ingredients Ingredient Name Strength WATER CARBOMER HOMOPOLYMER TYPE C DIMETHYL SULFONE DIMETHYL SULFOXIDE N-ACETYLGLUCOSAMINE GLUCOSAMINE HYDROCHLORIDE GLYCERYL STEARATE SE Polysorbate 80 CETOSTEARYL ALCOHOL ARNICA MONTANA CANNABIS SATIVA SEED OIL COCONUT OIL .ALPHA.-TOCOPHEROL ACETATE, DL- PHENOXYETHANOL ETHYLHEXYLGLYCERIN MAGNESIUM HYDROXIDE AMINOMETHYLPROPANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42452-379-01 0.114 kg in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/31/2020

Labeler — International Nutraceutical Company of America, LLC (941002250)

Registrant — International Nutraceutical Company of America, LLC (941002250)

Establishment
Name	Address	ID/FEI	Operations
Cosco International, Inc		016433141	manufacture (42452-379), relabel (42452-379), pack (42452-379)

Revised: 03/2020 International Nutraceutical Company of America, LLC