Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID e3e98530-ce4d-47b9-9383-3088814034eb
Route
TRANSDERMAL
Published
Effective Date 2021-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (35 mg)
Inactive Ingredients
Angelica Sinensis Root Atractylodes Lancea Root Angelica Dahurica Root Ginger Kaempferia Galanga Root Lanolin Mineral Oil Petrolatum Rosin Natural Latex Rubber Star Anise Fruit Styrene Isoprene 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

■ 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 plasters tightly closed in the zip-lock pouch

■ store at 15 to 30 C (59 to 86 F) in a dry place 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

■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

■ 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

■ do not apply heat to the area in form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

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

Section 50568-5

Ask a doctor or pharmacist before use if you have

■ any concerns about using this product

Section 50570-1

Do not use

■ on wounds

■ on irritated or damaged skin

■ if you are allergic to any ingredient in this product

Section 51727-6

Inactive ingredients angelica sinensis root, cang-zhu atractylodes rhizome, fragrant angelica root, ginger rhizome, kaempferia galanga rhizome, lanolin, mineral oil, petrolatum, rosin, rubber, star anise fruit, styrene-isoprene, and zinc oxide on a fabric backing covered with protective paper film.

Section 51945-4

Zhuanggu Gao Pain Relieving Plaster

NDC 68007-402-01

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

■ 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 plasters tightly closed in the zip-lock pouch

■ store at 15 to 30 C (59 to 86 F) in a dry place 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

■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

■ 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

■ do not apply heat to the area in form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you have

■ any concerns about using this product

Section 50570-1 (50570-1)

Do not use

■ on wounds

■ on irritated or damaged skin

■ if you are allergic to any ingredient in this product

Section 51727-6 (51727-6)

Inactive ingredients angelica sinensis root, cang-zhu atractylodes rhizome, fragrant angelica root, ginger rhizome, kaempferia galanga rhizome, lanolin, mineral oil, petrolatum, rosin, rubber, star anise fruit, styrene-isoprene, and zinc oxide on a fabric backing covered with protective paper film.

Section 51945-4 (51945-4)

Zhuanggu Gao Pain Relieving Plaster

NDC 68007-402-01

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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