Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 5a5c3759-90e0-4a93-99cf-ddbf00aba10d
Route
TRANSDERMAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (35 mg)
Inactive Ingredients
Angelica Sinensis Root Cinnamon Oil Erycibe Obtusifolia Stem Angelica Dahurica Root Frankincense Ginger Piper Kadsura Stem Lanolin Paprika Petrolatum Rosin Natural Latex Rubber Panax Notoginseng Root Stephania Sinica Whole Styrene Isoprene Turmeric Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-06-26 Until 2028-10-31

Description

Active Ingredients Menthol 3.5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert:This product contains natural rubber latex which may cause allergic reactions.

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

Clean the affected area. Remove the paper film from the patch, and place the patch on the affected area, so that the direction of stretch is consistent with joint action.

■ adults and children 2 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: consult your physician.

Description

Active Ingredients Menthol 3.5%

Section 44425-7

Other information

■ keep tightly sealed

■ store at 8 to 30 C (46 to 86 F), away from sunlight

Section 50565-1

Keep out of reach of childrento avoid accidental poisoning. 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

■ excessive irritation of the skin develops

■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

■ when using for pain of arthritis:

■ 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 or mucous membranes

■ do not bandage tightly

■ supervise use by children

■ use caution if prone to allergies

■ check carefully for hypersensitivity (skin reactions)

■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Section 50568-5

Ask a doctor or pharmacist before use if you have

■ using other medications

■ if pregnant or nursing

Section 50570-1

Do not use

■ on wounds

■ on large parts of the body for extended periods of time

■ on irritated or damaged skin

■ if properties of this product change

Section 51727-6

Inactive ingredients angelica sinensis root, cinnamon oil, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, lanolin, paprika, petrolatum, rosin, rubber, san-qi ginseng root, stephania (Stephania sinica Diels.) root, styrene-isoprene, turmeric rhizome, and zinc oxide on a fabric backing covered with protective paper film.

Section 51945-4

Gutong Tiegao Pain Relieving Plaster



NDC 68007-400-01



10 Patches

Each Patch 2.75 in x 4 in (7 cm x 10 cm)

5 Patches per Pouch

Section 53413-1

Questions or comments?

(888) 221-3496M-F 9 am to 5 pm

■ you may also report serious side effects to this phone number

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Active Ingredients

Menthol 3.5%


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

Clean the affected area. Remove the paper film from the patch, and place the patch on the affected area, so that the direction of stretch is consistent with joint action.

■ adults and children 2 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: consult your physician.

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert:This product contains natural rubber latex which may cause allergic reactions.

Section 44425-7 (44425-7)

Other information

■ keep tightly sealed

■ store at 8 to 30 C (46 to 86 F), away from sunlight

Section 50565-1 (50565-1)

Keep out of reach of childrento avoid accidental poisoning. 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

■ excessive irritation of the skin develops

■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

■ when using for pain of arthritis:

■ 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 or mucous membranes

■ do not bandage tightly

■ supervise use by children

■ use caution if prone to allergies

■ check carefully for hypersensitivity (skin reactions)

■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you have

■ using other medications

■ if pregnant or nursing

Section 50570-1 (50570-1)

Do not use

■ on wounds

■ on large parts of the body for extended periods of time

■ on irritated or damaged skin

■ if properties of this product change

Section 51727-6 (51727-6)

Inactive ingredients angelica sinensis root, cinnamon oil, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, lanolin, paprika, petrolatum, rosin, rubber, san-qi ginseng root, stephania (Stephania sinica Diels.) root, styrene-isoprene, turmeric rhizome, and zinc oxide on a fabric backing covered with protective paper film.

Section 51945-4 (51945-4)

Gutong Tiegao Pain Relieving Plaster



NDC 68007-400-01



10 Patches

Each Patch 2.75 in x 4 in (7 cm x 10 cm)

5 Patches per Pouch

Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496M-F 9 am to 5 pm

■ 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 3.5%


Advanced Ingredient Data


Raw Label Data

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