Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6dfe564b-1a70-4583-b622-ce55f1ecca5d
Route
TOPICAL
Published
Effective Date 2018-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (160 mg)
Inactive Ingredients
Glycerin Propylene Glycol Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-03-15
Description

Menthol 16%                                 Topical analgesic

Purpose

Menthol 16%                                 Topical analgesic

Medication Information

Purpose

Menthol 16%                                 Topical analgesic

Description

Menthol 16%                                 Topical analgesic

Uses

• temporarily relief of pain and itching associated with:

• arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Section 42229-5

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

Section 50565-1

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51945-4

Flammable

• do not use while smoking or near heat or flame

• avoid long term storage above 104​oF

• do not puncture or incinerate. Contents under pressure

• do not store at temperature above 120​oF

Directions

• shake well

• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily

• children under 12 years of age: consult a doctor

Inactive Ingredients

Glycerin, Propylene Glycol, SD Alcohol 40, Water

When Using This Product

• avoid contact with eyes and mucous membranes

• do not apply to wounds or damages skin

• do not bandage tightly

• use only as directed

Stop Use and Ask A Doctor If

• condition worsens

• symptoms last more than 7 days or clear up and occur again within a few days

•needed for longer than 1 week

Active Ingredient                          Purpose

Menthol 16%                                 Topical analgesic

Structured Label Content

Uses

• temporarily relief of pain and itching associated with:

• arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51945-4 (51945-4)

Flammable

• do not use while smoking or near heat or flame

• avoid long term storage above 104​oF

• do not puncture or incinerate. Contents under pressure

• do not store at temperature above 120​oF

Directions

• shake well

• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily

• children under 12 years of age: consult a doctor

Inactive Ingredients (Inactive ingredients)

Glycerin, Propylene Glycol, SD Alcohol 40, Water

When Using This Product (When using this product)

• avoid contact with eyes and mucous membranes

• do not apply to wounds or damages skin

• do not bandage tightly

• use only as directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition worsens

• symptoms last more than 7 days or clear up and occur again within a few days

•needed for longer than 1 week

Active Ingredient                          Purpose (Active ingredient                          Purpose)

Menthol 16%                                 Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:30.875429 · Updated: 2026-03-14T22:55:01.972489