Camphor 4%, Menthol 10%, Methyl Salicylate 30%

Camphor 4%, Menthol 10%, Methyl Salicylate 30%
SPL v1
SPL
SPL Set ID 38839f29-d4ce-4684-a3c7-0bb4bf1ad594
Route
TOPICAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (40 mg) Menthol, Unspecified Form (100 mg) Salicylic Acid (300 mg)
Inactive Ingredients
Carbomer Edetate Disodium Glyceryl Stearate Se Lanolin Polysorbate 80 Potassium Hydroxide Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-06
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50569-3

Ask a doctor before use if you have redness over the affected area

Section 55105-1
Active Ingredients Purpose
Camphor 4% Topical analgesic
Menthol 10% Topical analgesic
Methyl Salicylate 30% Topical analgesic

Warnings

For external use only.

Directions
  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use
  • on wounds or damaged skin
  • with a heating pad or apply external heat
  • on a child under 12 years of age with arthritis-like conditions
Other Information
  • store at 20° to 25°C (68° to 77°F)
  • Lot No. & Exp Date: See box or crimp of tube
Inactive Ingredients

Carbomer, disodium edetate, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, trolamine, water.

Questions and Comments?

Call 1-844-474-7464

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Principal Display Panel 113 G Tube Carton

Coolexa TM

Camphor, Menthol, Methyl Salicylate

4%, 10%, 30%

Topical analgesic cream

ULTRA STRENGTH

Net Wt. 4 oz (113 g)

Structured Label Content

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area

Section 55105-1 (55105-1)
Active Ingredients Purpose
Camphor 4% Topical analgesic
Menthol 10% Topical analgesic
Methyl Salicylate 30% Topical analgesic

Warnings

For external use only.

Directions
  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad or apply external heat
  • on a child under 12 years of age with arthritis-like conditions
Other Information
  • store at 20° to 25°C (68° to 77°F)
  • Lot No. & Exp Date: See box or crimp of tube
Inactive Ingredients

Carbomer, disodium edetate, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, trolamine, water.

Questions and Comments? (Questions and comments?)

Call 1-844-474-7464

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

Coolexa TM

Camphor, Menthol, Methyl Salicylate

4%, 10%, 30%

Topical analgesic cream

ULTRA STRENGTH

Net Wt. 4 oz (113 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:09:03.666639 · Updated: 2026-03-14T23:13:37.162375