Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 8a401732-54ef-ea10-e053-2a95a90a97fa

Route

TOPICAL

Published

Effective Date 2019-05-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Menthol (1 g) Camphor (natural)

Inactive Ingredients

Angelica Gigas Root Oil

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-05-11

Description

camphor, menthol

Medication Information

Warnings and Precautions

do not use if you have red rash, swell, itch, or any other abnormal physical symptoms while applying it on your body parts

do not use it on injured body parts, eczema, or dermatitis

keep it at a room temperature and out of children's reach

be careful not to get it in your eyes

Indications and Usage

apply it on body parts, for arms or legs, apply it on both sides together, and you can have better thermo-therapeutical effect

Dosage and Administration

for external use only

Description

camphor, menthol

Section 50565-1

keep out of reach of the children

Section 51727-6

ledum palustre extract, ginger extract, angelica gigas extract, etc

Section 51945-4

Section 55105-1

temporary relief of minor aches and pains of muscles and joints

Section 55106-9

camphor, menthol

Structured Label Content

Indications and Usage (34067-9)

apply it on body parts, for arms or legs, apply it on both sides together, and you can have better thermo-therapeutical effect

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

do not use if you have red rash, swell, itch, or any other abnormal physical symptoms while applying it on your body parts

do not use it on injured body parts, eczema, or dermatitis

keep it at a room temperature and out of children's reach

be careful not to get it in your eyes

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

ledum palustre extract, ginger extract, angelica gigas extract, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

temporary relief of minor aches and pains of muscles and joints

Section 55106-9 (55106-9)

camphor, menthol

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ANGELICA GIGAS ROOT OIL", "unii": "3EYY3K7TBB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "apply it on body parts, for arms or legs, apply it on both sides together, and you can have better thermo-therapeutical effect", "34068-7": "for external use only", "34071-1": "do not use if you have red rash, swell, itch, or any other abnormal physical symptoms while applying it on your body parts do not use it on injured body parts, eczema, or dermatitis keep it at a room temperature and out of children's reach be careful not to get it in your eyes", "50565-1": "keep out of reach of the children", "51727-6": "ledum palustre extract, ginger extract, angelica gigas extract, etc", "55105-1": "temporary relief of minor aches and pains of muscles and joints", "55106-9": "camphor, menthol"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:49.543549 · Updated: 2026-03-14T22:55:33.121473