Bt Pain Relief Patch

Bt Pain Relief Patch
SPL v1
SPL
SPL Set ID 251a133e-73ac-4d0e-bce7-30dcfc6b0de6
Route
TOPICAL
Published
Effective Date 2023-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (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

Description

Menthol 5% Methyl Salicylate 1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 5% Methyl Salicylate 1%

Uses

For the temporary relief of minor aches and pains of muscles associated with

•strains •bruises •sprains •simple backache •cold and dampness

Section 42229-5

Distributed by

Big 5 Nutrition LLC

Made in Taiwan

Section 50565-1

Keep out of reach of childrento avoid accidental poisoning.

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

Do not use otherwise than as directed.

Section 53413-1

Questions or comments?

www.twleaderlife.com

Warnings

For external use only

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

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 2 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

If pregnant, ask a health professional before use.

Packaging

Directions

• 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.

•Patch will remain effective for 6 hours.

•Avoid using the same patch on the same area for more than 6 hours.

•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 2 years of age: Do not use or consult a doctor.

Drug Facts

Other Information

•Store unused patch in the pouch

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

Active Ingredients

Menthol 5%

Methyl Salicylate 1%

Inactive Ingredients

Cinnamomum kanehirae Hayata Essential Oil, 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


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles associated with

•strains •bruises •sprains •simple backache •cold and dampness

Section 42229-5 (42229-5)

Distributed by

Big 5 Nutrition LLC

Made in Taiwan

Section 50565-1 (50565-1)

Keep out of reach of childrento avoid accidental poisoning.

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

Do not use otherwise than as directed.

Section 53413-1 (53413-1)

Questions or comments?

www.twleaderlife.com

Purpose

External analgesic

Warnings

For external use only

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

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 2 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

If pregnant, ask a health professional before use.

Packaging

Directions

• 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.

•Patch will remain effective for 6 hours.

•Avoid using the same patch on the same area for more than 6 hours.

•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 2 years of age: Do not use or consult a doctor.

Drug Facts

Other Information (Other information)

•Store unused patch in the pouch

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

Active Ingredients

Menthol 5%

Methyl Salicylate 1%

Inactive Ingredients (Inactive ingredients)

Cinnamomum kanehirae Hayata Essential Oil, 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


Advanced Ingredient Data


Raw Label Data

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