84165-013 Pro Cold & Hot Pain Relief Gel Roll-on (plantar Fasciitis)

84165-013 Pro Cold & Hot Pain Relief Gel Roll-on (plantar Fasciitis)
SPL v1
SPL
SPL Set ID 375bc794-3289-e610-e063-6294a90a4f9b
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Alcohol 95% Carbomer Triethanolamine .alpha.-tocopherol, D- Isopropyl Myristate Aloe Barbadensis Leaf Arnica Montana Flower Olibanum Camellia Sinensis Leaf Water Camphor (synthetic) Fd&c Blue No. 1 Glycerin Ilex Paraguariensis Leaf Fd&c Yellow No. 5 Silica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-12
Description

Menthol 4%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporary relieffrom minor aches and pains of sore muscles and joints associated with arthritisbackache, strains and sprains.

Dosage and Administration



Adults and Children above 12 years old:Rub a thin film over affected areas not more 4times daily; massage not necessary

Children under age of 12: Consult a doctor

Description

Menthol 4%

Section 50565-1



If swallowed accidentally, get medical help or contact 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 a few days.

Section 50567-7

use only as directed

avoid contact with eyes or mucous membranes

wash hands after use with cool water

store in a cool dry place away from direct sunlight

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 skin

do not bandage or use with heating pad or device

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 relieffrom minor aches and pains of sore muscles and joints associated with arthritisbackache, strains and sprains.

Dosage and Administration (34068-7)



Adults and Children above 12 years old:Rub a thin film over affected areas not more 4times 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 or contact 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 a few days.

Section 50567-7 (50567-7)

use only as directed

avoid contact with eyes or mucous membranes

wash hands after use with cool water

store in a cool dry place away from direct sunlight

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 skin

do not bandage or use with heating pad or device

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: 2026-02-15T12:06:17.886178 · Updated: 2026-03-14T23:08:59.288880