49e6f0ef-78fb-26fe-e063-6294a90a6655

SPL v1
SPL
SPL Set ID 49e6f0ef-78fb-26fe-e063-6294a90a6655
Route
topical
Published
Effective Date 2026-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (4 g)
Inactive Ingredients
mineral oil styrene ophiocordyceps sinensis dimethyl sulfone lavender oil chamomile flower oil gardenia jasminoides fruit ginger 1,2-hexanediol nitric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-02-01

Description

Active ingredient(s) Menthol 4.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

on wounds or damaged skin

with a heating pad

if you are allergic to menthol or any of the ingredients in this product

When using this product

avoid contact with eyes or mucous membranes

do not bandage tightly

use only as directed

keep away from excessive heat

Stop use and ask a doctor if rash occurs

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

Active Ingredient

Active ingredient(s)

Menthol 4.0%

Indications and Usage

Use(s)

■ temporarily relieves pain associated with minor:

muscle aches

joint pain

backache

strains and sprains

Dosage and Administration

Directions

adults and children 12 years and older:

apply to affected area not more than 1 to 2 times daily

rub in thoroughly until absorbed

children under 12 years of age:

ask a doctor

Description

Active ingredient(s) Menthol 4.0%

Section 50565-1

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

Section 51727-6

Inactive ingredients

Mineral Oil, Hydrogenated Dicyclopentadiene/Isopentene/Isoprene/Styrene Copolymer, Hydrogenated Styrene/Butadiene Copolymer, Silicate, Ginger, Soil mineral, Styrene Copolymer, Hydrogenated Styrene, Butadiene/Isoprene Copolymer, 1,2-Hexandiol, Lavender Oil, Chamomile Oil, Nitric oxide, Cordyceps Sinensis Extract, Gardenia, MSM

Section 51945-4

Section 53413-1

Questions

■ www.kbeone.com

Section 55105-1

Purpose

Topical analgesic

Section 60561-8

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

on wounds or damaged skin

with a heating pad

if you are allergic to menthol or any of the ingredients in this product

When using this product

avoid contact with eyes or mucous membranes

do not bandage tightly

use only as directed

keep away from excessive heat

Stop use and ask a doctor if rash occurs

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

Active Ingredient (55106-9)

Active ingredient(s)

Menthol 4.0%

Indications and Usage (34067-9)

Use(s)

■ temporarily relieves pain associated with minor:

muscle aches

joint pain

backache

strains and sprains

Dosage and Administration (34068-7)

Directions

adults and children 12 years and older:

apply to affected area not more than 1 to 2 times daily

rub in thoroughly until absorbed

children under 12 years of age:

ask a doctor

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

Mineral Oil, Hydrogenated Dicyclopentadiene/Isopentene/Isoprene/Styrene Copolymer, Hydrogenated Styrene/Butadiene Copolymer, Silicate, Ginger, Soil mineral, Styrene Copolymer, Hydrogenated Styrene, Butadiene/Isoprene Copolymer, 1,2-Hexandiol, Lavender Oil, Chamomile Oil, Nitric oxide, Cordyceps Sinensis Extract, Gardenia, MSM

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

■ www.kbeone.com

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 60561-8 (60561-8)

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light


Advanced Ingredient Data


Raw Label Data

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