84165-011 Heel Pain Relief Gel Roll-on

84165-011 Heel Pain Relief Gel Roll-on
SPL v1
SPL
SPL Set ID 36bacb5f-c1af-2e97-e063-6394a90afe5c
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.04 g)
Inactive Ingredients
Alcohol 95% Water .alpha.-tocopherol, D- Triethanolamine Arnica Montana Flower Camellia Sinensis Leaf Camphor (synthetic) Isopropyl Myristate Olibanum Glycerin Aloe Barbadensis Leaf Fd&c Blue No. 1 Ilex Paraguariensis Leaf Silica Fd&c Yellow No. 5 Carbomer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-04
Description

Menthol 4%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporary relief from minor aches and pains ofsore muscles and joints associated with arthritis,backache, strains and sprains.

Dosage and Administration



Adults and Children above 12 years old:

Rub a thin film over affected areas not more 4 times daily; massage not necessary

Children under age of 12: Consult a doctor

Description

Menthol 4%

Section 50565-1

If swallowed accidentally, get medical help orcontact with Poison Control Center immediately.

Section 50566-9

You experience pain, swelling or blistering;condition worsens, or if symptoms persist for morethan 7 days, or clear up and occur again within afew days.

Section 50567-7

use only as directed

avoid contact with eyes or mucous membranes

store in a cool dry place away from directsunlight

Section 50570-1



do not apply to wounds or damaged skin

do not use with other ointments, creams, sprays

or liniments

do not apply to irritated skinwash hands after use with cool water

do not bandage or use with heating pad ordevice

Section 51727-6

Alcohol

Aloe barbadensis leaf extract

Arnica montana flower extract

Boswellia carterii resin extract

Camellia sinensis leaf extract

Carbomer

Camphor

FD&C Blue 1

FD&C Yellow 5

Glycerin

Ilex Paraguariensis Leaf Extract

Isopropyl Myristate

Silica

Triethanolamine

Vitamin E

Water

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 4%

Structured Label Content

Indications and Usage (34067-9)

Temporary relief from minor aches and pains ofsore muscles and joints associated with arthritis,backache, strains and sprains.

Dosage and Administration (34068-7)



Adults and Children above 12 years old:

Rub a thin film over affected areas not more 4 times daily; massage not necessary

Children under age of 12: Consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed accidentally, get medical help orcontact with Poison Control Center immediately.

Section 50566-9 (50566-9)

You experience pain, swelling or blistering;condition worsens, or if symptoms persist for morethan 7 days, or clear up and occur again within afew days.

Section 50567-7 (50567-7)

use only as directed

avoid contact with eyes or mucous membranes

store in a cool dry place away from directsunlight

Section 50570-1 (50570-1)



do not apply to wounds or damaged skin

do not use with other ointments, creams, sprays

or liniments

do not apply to irritated skinwash hands after use with cool water

do not bandage or use with heating pad ordevice

Section 51727-6 (51727-6)

Alcohol

Aloe barbadensis leaf extract

Arnica montana flower extract

Boswellia carterii resin extract

Camellia sinensis leaf extract

Carbomer

Camphor

FD&C Blue 1

FD&C Yellow 5

Glycerin

Ilex Paraguariensis Leaf Extract

Isopropyl Myristate

Silica

Triethanolamine

Vitamin E

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 4%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:13.921148 · Updated: 2026-03-14T23:08:54.445441