Zhong Hua Feng Shi Die Da Gao External Analgesic Plaster

Zhong Hua Feng Shi Die Da Gao External Analgesic Plaster
SPL v2
SPL
SPL Set ID ceaa383d-8df0-1438-e053-2a95a90a2b6b
Route
TOPICAL
Published
Effective Date 2021-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.01 g) Menthol, Unspecified Form (0.04 g)
Inactive Ingredients
Clematis Chinensis Root Pinus Massoniana Resin Yellow Ob Ricinus Communis Seed Yellow Wax Momordica Cochinchinensis Seed Sesame Oil Zinc Oxide Myrrh Frankincense Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-11

Description

Analgesic


Medication Information

Description

Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

● arthritis ● strains ● bruises ● sprains ● simple backache

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right

away.

Section 50565-1

Keep out of reach of childrento avoid accidental poisoning.

Section 50570-1

Do not use otherwise than as directed.

Section 53414-9

If pregnant, ask a health professional before use.

Section 55105-1

Analgesic

Section 55106-9
Active Ingredients Purpose
Menthol 4% External Analgesic
Methyl Salicylate 1% External Analgesic

Warnings

For external use only

Directions

● Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.

● Plaster will remain effective for 8 hours.

● Avoid using the same patch on the same area for more than 2 days.

● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.

● Wet patch with warm water before removing from skin.

● Children under 12 years of age: Do not use or consult a doctor.

Do Not Use

● on wounds ● irritated or damaged skin ● sensitive skin

● with a heating pad ● if pregnant

● with, or as the same time as, other external analgesic products

● if allergic to aspirin or salicylates

● if allergic to any ingredients of this product

Package Label

Other Information

●Store unused patch in the pouch

●Store at room temperature, 20 to 25°C(68 to 77°F)

Lnactive Ingredients

Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide

Questions Or Comments

Call:1-800-796-1888

When Using This Product

● avoid contact with the eyes

● do not bandage tightly

● do not apply to wounds or damaged skin

● do not use more than 3 plasters a day

● do not use 1 hour before or after bathing

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

● rashes, itching or redness are present

● side effects occur.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

● arthritis ● strains ● bruises ● sprains ● simple backache

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right

away.

Section 50565-1 (50565-1)

Keep out of reach of childrento avoid accidental poisoning.

Section 50570-1 (50570-1)

Do not use otherwise than as directed.

Section 53414-9 (53414-9)

If pregnant, ask a health professional before use.

Section 55105-1 (55105-1)

Analgesic

Section 55106-9 (55106-9)
Active Ingredients Purpose
Menthol 4% External Analgesic
Methyl Salicylate 1% External Analgesic

Warnings

For external use only

Directions

● Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.

● Plaster will remain effective for 8 hours.

● Avoid using the same patch on the same area for more than 2 days.

● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.

● Wet patch with warm water before removing from skin.

● Children under 12 years of age: Do not use or consult a doctor.

Do Not Use (Do not use)

● on wounds ● irritated or damaged skin ● sensitive skin

● with a heating pad ● if pregnant

● with, or as the same time as, other external analgesic products

● if allergic to aspirin or salicylates

● if allergic to any ingredients of this product

Package Label

Other Information

●Store unused patch in the pouch

●Store at room temperature, 20 to 25°C(68 to 77°F)

Lnactive Ingredients (lnactive ingredients)

Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide

Questions Or Comments (Questions or Comments)

Call:1-800-796-1888

When Using This Product (When using this product)

● avoid contact with the eyes

● do not bandage tightly

● do not apply to wounds or damaged skin

● do not use more than 3 plasters a day

● do not use 1 hour before or after bathing

Stop Use and Ask A Doctor If (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

● rashes, itching or redness are present

● side effects occur.


Advanced Ingredient Data


Raw Label Data

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