eca2e68f-7c1c-4887-ae6b-fa66b31f535f

SPL v1
SPL
SPL Set ID eca2e68f-7c1c-4887-ae6b-fa66b31f535f
Route
topical
Published
Effective Date 2012-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.025 g)
Inactive Ingredients
camphor (synthetic) carbomer 940 dmdm hydantoin isoceteth-20 isopropyl alcohol polyoxyl 40 hydrogenated castor oil sodium hydroxide water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-12-17
Description

Active Ingredient Menthol 2.5%

Medication Information

Warnings and Precautions

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • Avoid contact with eyes or mucous membranes.
  • Discontinue use if excessive irritation of the skin develops.
  • Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
  • If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • For arthritis like conditions in children under 12, do not use. Consult a doctor.
Active Ingredient

Active Ingredient

Menthol 2.5%

Indications and Usage

Uses

  • Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.
Dosage and Administration

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
  • Children under 12 years of age: do not use, consult a doctor
Description

Active Ingredient Menthol 2.5%

Section 42229-5

Other Information

  • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • Lot No. Exp. Date: see crimp of tube.
Section 50565-1
  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 51727-6

Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water

Section 51945-4

Section 55105-1

Purpose

Topical Analgesic

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • Avoid contact with eyes or mucous membranes.
  • Discontinue use if excessive irritation of the skin develops.
  • Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
  • If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • For arthritis like conditions in children under 12, do not use. Consult a doctor.
Active Ingredient (55106-9)

Active Ingredient

Menthol 2.5%

Indications and Usage (34067-9)

Uses

  • Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.
Dosage and Administration (34068-7)

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
  • Children under 12 years of age: do not use, consult a doctor
Section 42229-5 (42229-5)

Other Information

  • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • Lot No. Exp. Date: see crimp of tube.
Section 50565-1 (50565-1)
  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 51727-6 (51727-6)

Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.287316 · Updated: 2026-03-14T22:53:21.930902