Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d3ede306-9ef7-4a89-896b-c083f6e43c85
Route
TOPICAL
Published
Effective Date 2012-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.4 mg) Levomenthol (1.8 mg) Salicylic Acid (2 mg)
Inactive Ingredients
Butylated Hydroxytoluene Natural Latex Rubber Calcium Carbonate Sorbitan Monostearate Alpha-tocopherol Acetate Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-25
Description

DL-Camphor 1.2% L-Menthol 5.7% Methyl Salicylate 6.3%

Purpose

Topical Analgesic Topical Analgesic Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Description

DL-Camphor 1.2% L-Menthol 5.7% Methyl Salicylate 6.3%

Uses

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

  • arthritis
  • simple backaches
  • strains
  • bruises
  • sprains
Warnings

for external use only

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 to 4 times daily for 7 days
  • wear up to 8 hours per application

Children under 12 years of age:

  • consult a doctor

Do Not Use
  • on wounds or damaged skin
  • if you are allergic to aspirin or salicylates
  • with a heating pad
  • with, or at the same time as, other external analgesic products

Carton Label

Pain Relief Patch

Active Ingredient

DL-Camphor 1.2%

L-Menthol 5.7%

Methyl Salicylate 6.3%

Other Information
  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive Ingredients

butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quintone, sorbitan stearate, tocopherol acetate, ys resin, zinc oxide

When Using This Product
  • use only as directed
  • avoid contact with eyes, mucous membranes or rashes

Ask A Doctor Before Use,

if you are allergic to any ingredients of this product.

Stop Use and Ask A Doctor If
  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms 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.

Structured Label Content

Uses

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

  • arthritis
  • simple backaches
  • strains
  • bruises
  • sprains
Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Warnings

for external use only

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 to 4 times daily for 7 days
  • wear up to 8 hours per application

Children under 12 years of age:

  • consult a doctor

Do Not Use (Do not use)
  • on wounds or damaged skin
  • if you are allergic to aspirin or salicylates
  • with a heating pad
  • with, or at the same time as, other external analgesic products

Carton Label (Carton label)

Pain Relief Patch

Active Ingredient (Active ingredient)

DL-Camphor 1.2%

L-Menthol 5.7%

Methyl Salicylate 6.3%

Other Information (Other information)
  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quintone, sorbitan stearate, tocopherol acetate, ys resin, zinc oxide

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes, mucous membranes or rashes

Ask A Doctor Before Use, (Ask a doctor before use,)

if you are allergic to any ingredients of this product.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.224128 · Updated: 2026-03-14T22:54:55.117494