SPL v2
SPL
SPL Set ID 1758ef9b-4fac-4066-e063-6394a90a8cc3
Route
TOPICAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (57.6 mg) Camphor (synthetic) (96 mg) Levomenthol (76.8 mg)
Inactive Ingredients
Methylparaben Edetate Disodium Tartaric Acid Carboxymethylcellulose Sodium Sorbitol Gelatin Castor Oil Sodium Polyacrylate (8000 Mw) Nonivamide Glyceryl Monostearate Aloe Vera Leaf Butylated Hydroxytoluene Water Polysorbate 80 Titanium Dioxide Aluminum Hydroxide Kaolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

L-Menthol 76.8mg Methyl Salicylate 57.6mg DL-Camphor 96.0mg

Purpose

Topical Analgesic


Medication Information

Warnings and Precautions

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.



Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • with a heating pad

When using this product

  • use only as directed
  • avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

  • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • condition worsens
  • symptoms persist for longer than 7 days
  • symptoms clear up and reoccur within a few days

If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
Purpose

Topical Analgesic

Description

L-Menthol 76.8mg Methyl Salicylate 57.6mg DL-Camphor 96.0mg

Section 51945-4

Directions

Adults and children 12 years of age and over:

■ clean and dry affected area

■ remove patch from film

■ apply to affected area not more than 3 times daily

■ remove patch from skin after at most 8 hours of application

children under 12 years of age:Consult a doctor

Other Information

■ avoid storing product in direct sunlight

■ protect product from excessive moisture

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Inactive Ingredients

Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,

Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water

Keep Out Or Reach of Children

Keep out of reach of children.

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


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
Warnings and Precautions (34071-1)

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.



Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • with a heating pad

When using this product

  • use only as directed
  • avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

  • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • condition worsens
  • symptoms persist for longer than 7 days
  • symptoms clear up and reoccur within a few days

If pregnant or breast-feeding, ask a health professional before use.

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Directions

Adults and children 12 years of age and over:

■ clean and dry affected area

■ remove patch from film

■ apply to affected area not more than 3 times daily

■ remove patch from skin after at most 8 hours of application

children under 12 years of age:Consult a doctor

Other Information

■ avoid storing product in direct sunlight

■ protect product from excessive moisture

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Inactive Ingredients

Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,

Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water

Keep Out Or Reach of Children (Keep out or reach of children)

Keep out of reach of children.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)