Muscle Rub

Muscle Rub
SPL v4
SPL
SPL Set ID 163ba925-b26a-4737-8c05-68875435452b
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (15 g)
Inactive Ingredients
Isopropyl Myristate Methylparaben Phenoxyethanol Sodium Hydroxide Stearic Acid Edetate Disodium Anhydrous Water Allantoin Carboxypolymethylene Dimethicone Cetyl Alcohol Titanium Dioxide Alpha-tocopherol Acetate Xanthan Gum Potassium Cetyl Phosphate Propylparaben Polysorbate 20 Glycerin Glyceryl Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01
Description

Menthol 10% Methyl Salicylate USP 15%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 10% Methyl Salicylate USP 15%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Label

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 53413-1

Call 1-833-605-84-74 9am-5 pm EST M-F

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor
Do Not Use On

wounds or damaged skin

Active Ingredient

Menthol 10%

Methyl Salicylate USP 15%

Other Information

■ Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal ■ Store at room temperature ■ See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients



Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

When Using This Product
  • avoid contact with eyes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Label

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 53413-1 (53413-1)

Call 1-833-605-84-74 9am-5 pm EST M-F

Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor
Do Not Use On (Do not use on)

wounds or damaged skin

Active Ingredient

Menthol 10%

Methyl Salicylate USP 15%

Other Information

■ Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal ■ Store at room temperature ■ See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients



Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:35.368137 · Updated: 2026-03-14T23:13:40.815212