84165-009 Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-on

84165-009 Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-on
SPL v1
SPL
SPL Set ID 35285d62-c660-a056-e063-6294a90aabc8
Route
TOPICAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-15

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



Aduits 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 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.

wash hands after use with cool water.

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 ordewice.

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)



Aduits 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 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.

wash hands after use with cool water.

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 ordewice.

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)