herbal utaplas external analgesic plaster

herbal utaplas external analgesic plaster
SPL v1
SPL
SPL Set ID aeaf070f-4512-4b8f-9bd8-960f6bb82881
Route
topical
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (0.06 g) salicylic acid (0.1 g)
Inactive Ingredients
clematis chinensis root indigotindisulfonate sodium momordica cochinchinensis seed myrrh frankincense pinus massoniana resin ricinus communis seed sesame oil fd&c yellow no. 5 yellow wax zinc oxide

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: green
Marketing Status
otc monograph drug active Since 2024-01-01

Purpose

External Analgesic

Description

Menthol               5% Methyl Salicylate 1%


Medication Information

Warnings

For external use only

Uses

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

● arthritis ● strains ● bruises ● sprains ● simple backache

Purpose

External Analgesic

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.

Other Information

●Store unused patch in the pouch

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

Inactive 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

Description

Menthol               5% Methyl Salicylate 1%

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.

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.

Drug Facts

Package Label

Active Ingredients

Menthol               5%

Methyl Salicylate 1%

Questions Or Comments

Call:1-888-811-1133

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

Warnings

For external use only

Uses

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

● arthritis ● strains ● bruises ● sprains ● simple backache

Purpose

External Analgesic

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.

Other Information

●Store unused patch in the pouch

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

Inactive Ingredients (Inactive 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

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.

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.

Drug Facts

Package Label

Active Ingredients

Menthol               5%

Methyl Salicylate 1%

Questions Or Comments (Questions or Comments)

Call:1-888-811-1133

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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