Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 7239a241-afbf-4877-8608-59dff8d16187
Route
TOPICAL
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (15 g)
Inactive Ingredients
Scutellaria Baicalensis Root Glycyrrhiza Uralensis Whole Cinnamon Oil Daemonorops Draco Resin Peppermint Oil Camellia Oil

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-05-10

Description

Active ingredients Menthol 15%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration

Directions

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: Do not use, consult your doctor

Description

Active ingredients Menthol 15%

Section 44425-7

Other information

keep container tightly closed

store at 15 to 30C (59 to 86F)

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

when using for pain of arthritis if:

pain persists for more than 10 days

redness is present

in conditions affecting children under 12 years of age

Section 50567-7

When using this product

avoid contact with the eyes

do not bandage tightly

Section 50570-1

Do not use

on wounds

on damaged skin

if excessive irritation develops

Section 51727-6

Inactive ingredients

BaikaL Skullcap (Huang-Qin) Root, Chinese Licorice (Gan-Zao) Root, Cinnamon Oil, Dragon’s Blood (Xue-Jie) Resin, Peppermint Oil, and Tea Oil.

Section 51945-4

PO SUM ON MEDICATED OIL, EXTERNAL ANALGESIC, NDC 54155-052-02, FREE SAMPLE, NOT FOR RESALE, 0.19 fl. oz (5.6 ML)

Section 53413-1

Questions or comments? (888)221-3496 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredients

Menthol 15%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration (34068-7)

Directions

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: Do not use, consult your doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store at 15 to 30C (59 to 86F)

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

when using for pain of arthritis if:

pain persists for more than 10 days

redness is present

in conditions affecting children under 12 years of age

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes

do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds

on damaged skin

if excessive irritation develops

Section 51727-6 (51727-6)

Inactive ingredients

BaikaL Skullcap (Huang-Qin) Root, Chinese Licorice (Gan-Zao) Root, Cinnamon Oil, Dragon’s Blood (Xue-Jie) Resin, Peppermint Oil, and Tea Oil.

Section 51945-4 (51945-4)

PO SUM ON MEDICATED OIL, EXTERNAL ANALGESIC, NDC 54155-052-02, FREE SAMPLE, NOT FOR RESALE, 0.19 fl. oz (5.6 ML)

Section 53413-1 (53413-1)

Questions or comments? (888)221-3496 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Menthol 15%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)