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 Tube Label

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

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