OARS AND ALPS MUSCLE RECOVERY BALM- menthol, methyl salicylate cream 
Cosco International, Inc

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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OARS + ALPS MUSCLE RECOVERY BALM

DRUG FACTS

Menthol - 5%....................................External Analgesic
Methyl Salicylate (NSAID) – 10%.........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:

For external use only.

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

Do not use on wounds or damaged skin, with a heating pad, on a child under 12 years of age with arthritis-like condition.

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, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexylglycerin, Octyl Palmitate, Fragrance, Glucosamine, Glyceryl Monostearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Turmeric Oil, Water

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat

Questions or comments?

Contact Hi@oarsandalps.com

Allergy Alert:

Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

3oz label

OARS AND ALPS MUSCLE RECOVERY BALM 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-6300
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 SALICYLATE0.1 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)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ARNICA MONTANA (UNII: O80TY208ZW)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
TURMERIC OIL (UNII: 6KGS8SP16U)  
OCTYL PALMITATE (UNII: UYY8LE6Q5Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-6300-10.085 kg in 1 TUBE; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/14/2022
Labeler - Cosco International, Inc (016433141)
Registrant - Cosco International, Inc (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc016433141manufacture(52261-6300) , label(52261-6300) , pack(52261-6300)

Revised: 2/2022
Document Id: 72c3c6d3-3074-4b28-bc09-f9564b0a4358
Set id: 8745802f-018d-4cf8-bbf3-3b04c8f54538
Version: 1
Effective Time: 20220214
 
Cosco International, Inc