Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 3f12da60-26d1-4407-8e02-c3213ea3ad2a
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 Pubescens Root Rosin Natural Latex Rubber Safflower Biancaea Sappan Wood Dipsacus Asper Root Styrene Isoprene Zinc Oxide Achyranthes Bidentata Root Angelica Sinensis Root Ocimum Gratissimum Whole Chinese Cinnamon Clematis Chinensis Root Paeonia Veitchii Root Cinnamon Oil Dragon's Blood Angelica Dahurica Root Frankincense Piper Kadsura Stem Knoxia Roxburghii Subsp. Brunonis Root Lanolin Lesser Galangal Root Lindera Aggregata Root Mineral Oil Myrrh Notopterygium Incisum Root Paprika Periploca Sepium Root Bark Prunus Persica Seed Petrolatum

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 patch

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 irritated or damaged skin

■ on wounds

■ if you are allergic to any ingredient in this product

Section 51727-6

Inactive ingredients achyranthes root, angelica sinensis root, basil oil, cassia bark, Chinese clematis root and rhizome, Chinese peony root with bark, cinnamon oil, dragon’s blood resin, fragrant angelica root, frankincense oleo-gum-resin, kadsura pepper stem, knoxia root, lanolin, lesser galangal rhizome, lindera root, mineral oil, myrrh oleo-gum-resin, notopterygium rhizome and root, paprika, periplocae cortex, persicae semen, petrolatum, pubescent angelica root, rosin, rubber, safflower, sappanwood heartwood, sichuan teasel root, styrene-isoprene, and zinc oxide on a cotton pad and covered with a protective paper film.

Section 51945-4

Zhuifeng Gao Pain Relieving Plaster

NDC 68007-403-01

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 patch

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 irritated or damaged skin

■ on wounds

■ if you are allergic to any ingredient in this product

Section 51727-6 (51727-6)

Inactive ingredients achyranthes root, angelica sinensis root, basil oil, cassia bark, Chinese clematis root and rhizome, Chinese peony root with bark, cinnamon oil, dragon’s blood resin, fragrant angelica root, frankincense oleo-gum-resin, kadsura pepper stem, knoxia root, lanolin, lesser galangal rhizome, lindera root, mineral oil, myrrh oleo-gum-resin, notopterygium rhizome and root, paprika, periplocae cortex, persicae semen, petrolatum, pubescent angelica root, rosin, rubber, safflower, sappanwood heartwood, sichuan teasel root, styrene-isoprene, and zinc oxide on a cotton pad and covered with a protective paper film.

Section 51945-4 (51945-4)

Zhuifeng Gao Pain Relieving Plaster

NDC 68007-403-01

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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