Oars + Alps Muscle Recovery Balm

Oars + Alps Muscle Recovery Balm
SPL v2
SPL
SPL Set ID 8745802f-018d-4cf8-bbf3-3b04c8f54538
Route
TOPICAL
Published
Effective Date 2025-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.05 kg) Salicylic Acid (0.1 kg)
Inactive Ingredients
Water Carbomer Homopolymer Type C Dimethyl Sulfone Dimethyl Sulfoxide N-acetylglucosamine Glyceryl Monostearate Polysorbate 80 Cetostearyl Alcohol Arnica Montana .alpha.-tocopherol Acetate, Dl- Phenoxyethanol Ethylhexylglycerin Magnesium Hydroxide Aminomethylpropanol Turmeric Oil Octyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-14

Description

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


Medication Information

Indications and Usage

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

Description

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

Section 50565-1

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

Section 50566-9

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

Section 50569-3

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.

Section 50570-1

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

Section 51945-4

Warnings:

For external use only.

Drug Facts

Menthol - 5%....................................External Analgesic

Methyl Salicylate (NSAID) – 10%.........External Analgesic

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.

Allergy Alert:

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

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)

Do not expose to excessive heat

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

Questions Or Comments?

Structured Label Content

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

Indications and Usage (34067-9)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Warnings:

For external use only.

Drug Facts (DRUG FACTS)

Menthol - 5%....................................External Analgesic

Methyl Salicylate (NSAID) – 10%.........External Analgesic

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.

Allergy Alert:

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

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)

Do not expose to excessive heat

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

Questions Or Comments? (Questions or comments?)

Advanced Ingredient Data


Raw Label Data

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