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SPL v3
SPL
SPL Set ID f49e718b-ef89-b648-e053-2a95a90a96c8
Route
topical
Published
Effective Date 2023-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (9.6 mg)
Inactive Ingredients
caprylhydroxamic acid glycerin citrus limon fruit oil rosmarinus officinalis flowering top oil eucalyptus oil gaultheria procumbens leaf water carbomer homopolymer, unspecified type methyl salicylate arnica montana camphor oil, white pine needle oil (pinus sylvestris) polysorbate 80 caprylyl glycol glyceryl caprylate mentha piperita

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-07-27
Description

Menthol 9.6%

Medication Information

Warnings and Precautions

■ For external use only.

■ Avoid Contact with the eyes. If conditions worsen, or if symptoms

persist for more that 7 days or clear up and occur again within a few

days, discontinue use of this product and consult a physician/doctor.

■ Do not apply to wounds or damaged skin.

■ Do not bandage tightly.

■ Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Indications and Usage

■ For the temporary relief of minor aches and pains of muscles and joints

associated with simple backache, arthritis, strains, bruises, and sprains.

For penetrating pain relief.

Dosage and Administration

■ Adults and children 2 years of age and older:

Apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: consult a Physician/Doctor

Description

Menthol 9.6%

Section 50565-1

■ Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Section 51727-6

Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin,

Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil

Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil,

Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens

(Wintergreen) Oil, Cinnamomum Camphora (White) Oil,

Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.

Section 51945-4

Section 55105-1

Pain Relieving Gel

Active Ingredients

Menthol 9.6%

Structured Label Content

Warnings and Precautions (34071-1)

■ For external use only.

■ Avoid Contact with the eyes. If conditions worsen, or if symptoms

persist for more that 7 days or clear up and occur again within a few

days, discontinue use of this product and consult a physician/doctor.

■ Do not apply to wounds or damaged skin.

■ Do not bandage tightly.

■ Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Indications and Usage (34067-9)

■ For the temporary relief of minor aches and pains of muscles and joints

associated with simple backache, arthritis, strains, bruises, and sprains.

For penetrating pain relief.

Dosage and Administration (34068-7)

■ Adults and children 2 years of age and older:

Apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: consult a Physician/Doctor

Section 50565-1 (50565-1)

■ Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin,

Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil

Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil,

Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens

(Wintergreen) Oil, Cinnamomum Camphora (White) Oil,

Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain Relieving Gel

Active Ingredients

Menthol 9.6%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:27.014031 · Updated: 2026-03-14T23:07:17.257844