28167e2a-9afb-44e7-90c7-9577df9504b6

SPL v3
SPL
SPL Set ID 28167e2a-9afb-44e7-90c7-9577df9504b6
Route
topical
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (10 g) menthol (3 g) camphor (natural)
Inactive Ingredients
arnica montana whole carbomer homopolymer type c (allyl pentaerythritol crosslinked) cat's claw maytenus macrocarpa bark harpagophytum procumbens root glucosamine sulfate isopropyl alcohol peg-40 sorbitan diisostearate trolamine water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-03-01
Purpose

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

Description

Active Ingredients Purpose Methyl Salicylate 10% Topical Analgesic Menthol 3% Topical Analgesic Camphor 3% Topical Analgesic

Medication Information

Warnings

For the external use only.

  • Avoid contact with eyes and mucous membranes.
  • Do not use otherwise than as directed

Caution:Discontinue use if excessive irritation of the skin develops.

Indications and Usage

Purpose

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

Description

Active Ingredients Purpose Methyl Salicylate 10% Topical Analgesic Menthol 3% Topical Analgesic Camphor 3% Topical Analgesic

Active Ingredients
Active Ingredients Purpose
Methyl Salicylate 10% Topical Analgesic
Menthol 3% Topical Analgesic
Camphor 3% Topical Analgesic

Inactive Ingredient

Arnica Montana Extract, Carbopol 940,Cat's Claw Extract, Chuchuhuasi Extract, Devil's Claw Extract, Glucosamine Sulfate,Isopropil Alcohol, Peg 40 Castor Oil, Purified Water, Triethanolamine

Dosage & Administration

Adults and children 18 years of age and older: Spray a thin layer over the affected area not more than 3 to 4 times daily.

Children under 18 years of age: Consult a doctor.

Santo Remedio Aerobic Sports

QUANTIUMMED DISTRIBUTORS, INC

MIAMI - FL, 33172

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children

Stop Use and Ask A Doctor If:
  • Conditions worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
When Using This Product Use As Directed.
  • Do not bandage tightly.
  • Do not apply to wounds or damaged skin.

Structured Label Content

Warnings (WARNINGS)

For the external use only.

  • Avoid contact with eyes and mucous membranes.
  • Do not use otherwise than as directed

Caution:Discontinue use if excessive irritation of the skin develops.

Indications and Usage (34067-9)

Purpose (PURPOSE)

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

Active Ingredients (ACTIVE INGREDIENTS)
Active Ingredients Purpose
Methyl Salicylate 10% Topical Analgesic
Menthol 3% Topical Analgesic
Camphor 3% Topical Analgesic

Inactive Ingredient (INACTIVE INGREDIENT)

Arnica Montana Extract, Carbopol 940,Cat's Claw Extract, Chuchuhuasi Extract, Devil's Claw Extract, Glucosamine Sulfate,Isopropil Alcohol, Peg 40 Castor Oil, Purified Water, Triethanolamine

Dosage & Administration (DOSAGE & ADMINISTRATION)

Adults and children 18 years of age and older: Spray a thin layer over the affected area not more than 3 to 4 times daily.

Children under 18 years of age: Consult a doctor.

Santo Remedio Aerobic Sports

QUANTIUMMED DISTRIBUTORS, INC

MIAMI - FL, 33172

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

Ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Conditions worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
When Using This Product Use As Directed. (When using this product use as directed.)
  • Do not bandage tightly.
  • Do not apply to wounds or damaged skin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.381184 · Updated: 2026-03-14T23:01:55.379030