Drug Facts - Ultra Strength Muscle Rub

Drug Facts - Ultra Strength Muscle Rub
SPL v1
SPL
SPL Set ID 2ea95529-ec4b-c2ce-e063-6394a90a0739
Route
TOPICAL
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (40 mg) Salicylic Acid (300 mg) Menthol (100 mg)
Inactive Ingredients
Cocos Nucifera (coconut) Oil Water Sodium Hydroxide Edetate Disodium Lanolin Polysorbate 60 Stearic Acid Glyceryl Stearate Mineral Oil Isopropyl Myristate Aloe Barbadensis Leaf Sodium Lauryl Sulfate Carbomer Homopolymer Type C Vitamin E Polyethylene Glycol Succinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-15

Description

Camphor 4% Menthol 10% Methyl salicylate 30%

Purpose

Camphor - Topical analgesic Menthol - Topical analgesic Methyl salicylate - Topical analgesic


Medication Information

Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Description

Camphor 4% Menthol 10% Methyl salicylate 30%

Uses
  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Warnings

For external use only

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Active Ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Inactive Ingredients

aloe barbadensis leaf extract, carbomer homopolymer, cocos nucifera (coconut) oil, edetate disodium, glyceryl stearate, isopropyl myristate, lanolin, mineral oil, polysorbate 60, purified water, sodium hydroxide, sodium lauryl sulfate, stearic acid, vitamin E

When Using This Product
  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat
Stop Use and Ask A Doctor If
  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Package Label. Principal Display Panel


Structured Label Content

Uses
  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Warnings

For external use only

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Active Ingredient (Active ingredient)

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, carbomer homopolymer, cocos nucifera (coconut) oil, edetate disodium, glyceryl stearate, isopropyl myristate, lanolin, mineral oil, polysorbate 60, purified water, sodium hydroxide, sodium lauryl sulfate, stearic acid, vitamin E

When Using This Product (When using this product)
  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Package Label. Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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