SPL v2
SPL
SPL Set ID 402faa27-5305-c73d-e063-6394a90a36f2
Route
TOPICAL
Published
Effective Date 2026-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Hydroxyacetophenone Water Polyoxyl 40 Hydrogenated Castor Oil Portulaca Grandiflora Leaf Propylene Glycol Carbomer Homopolymer, Unspecified Type Glycerin Edetate Disodium Chrysanthemum Indicum Top Mentha Arvensis Leaf 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-02

Description

Active ingredient Menthol 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains

Dosage and Administration

- Adults and children 12 years and older:

Clean the affected area with mild soap and warm water, then pat dry.

Apply a thin, even layer to the affected area not more than 3 to 4 times

daily.

- Children under 12 years: consult a doctor

Description

Active ingredient Menthol 5%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if: condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Section 50567-7

avoid contact with eyes,

mucous membranes do not bandage tightly

Section 50570-1

on wounds or damaged skin with a heating pad

if allergic to menthol or any ingredient in this product

Section 51727-6

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,

Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,

Mentha Arvensis Leaf, Chrysanthemum Indicum Top,

Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1

Temporary relief of minor aches and pains

Section 55106-9

Active ingredient

Menthol 5%

Section 60561-8

Store at 15–30°C (59–86°F)

Protect from excessive moisture and direct sunlight

Keep the carton for full labeling

Flammable: keep away from fire or flame


Structured Label Content

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, sprains

Dosage and Administration (34068-7)

- Adults and children 12 years and older:

Clean the affected area with mild soap and warm water, then pat dry.

Apply a thin, even layer to the affected area not more than 3 to 4 times

daily.

- Children under 12 years: consult a doctor

Warnings and Precautions (34071-1)

For external use only

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 50566-9 (50566-9)

Stop use and ask a doctor if: condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Section 50567-7 (50567-7)

avoid contact with eyes,

mucous membranes do not bandage tightly

Section 50570-1 (50570-1)

on wounds or damaged skin with a heating pad

if allergic to menthol or any ingredient in this product

Section 51727-6 (51727-6)

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,

Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,

Mentha Arvensis Leaf, Chrysanthemum Indicum Top,

Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1 (55105-1)

Temporary relief of minor aches and pains

Section 55106-9 (55106-9)

Active ingredient

Menthol 5%

Section 60561-8 (60561-8)

Store at 15–30°C (59–86°F)

Protect from excessive moisture and direct sunlight

Keep the carton for full labeling

Flammable: keep away from fire or flame


Advanced Ingredient Data


Raw Label Data

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