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

OARS AND ALPS MUSCLE RECOVERY BALM by

Drug Labeling and Warnings

OARS AND ALPS MUSCLE RECOVERY BALM by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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 condition.

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.

INDICATIONS & USAGE

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

STOP USE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OARS AND ALPS MUSCLE RECOVERY BALM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-6300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 kg  in 1 kg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.1 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-6300-1	0.085 kg in 1 TUBE; Type 0: Not a Combination Product	02/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/14/2022

Labeler - Cosco International, Inc (016433141)

Registrant - Cosco International, Inc (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc		016433141	manufacture(52261-6300) , label(52261-6300) , pack(52261-6300)