REVALIFE PAIN RELIEF CREAM- menthol, 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.

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Revalife - Pain Relief Cream

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

tube label

sachet label

REVALIFE PAIN RELIEF CREAM 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42452-379
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 kg  in 1 kg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.075 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42452-379-010.114 kg in 1 TUBE; Type 0: Not a Combination Product03/31/2020
2NDC:42452-379-000.00288 kg in 1 PACKET; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/31/2020
Labeler - International Nutraceutical Company of America, LLC (941002250)
Registrant - International Nutraceutical Company of America, LLC (941002250)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc016433141manufacture(42452-379) , label(42452-379) , pack(42452-379)

Revised: 2/2022
Document Id: 291a7722-a53d-4827-b9f6-897226369d92
Set id: 2b7e9ef7-f777-4b50-bf30-20e880b230a1
Version: 3
Effective Time: 20220214
 
International Nutraceutical Company of America, LLC