BT PAIN RELIEF- menthol, methyl salicylate patch

BT Pain Relief by

Drug Labeling and Warnings

BT Pain Relief by is a Otc medication manufactured, distributed, or labeled by Big 5 Nutrition LLC, Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 5%
Methyl Salicylate 1%

Purpose

External analgesic

Uses

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

strains bruises sprains simple backache cold and dampness

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.

KEEP OUT OF REACH OF CHILDREN

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.

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.

Other information

Store unused patch in the pouch
Store at room temperature, 20° to 25° C (68°  to 77° F)

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

QUESTIONS

Questions or comments?

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SPL UNCLASSIFIED SECTION

Distributed by

Big 5 Nutrition LLC

Made in Taiwan

Packaging

INGREDIENTS AND APPEARANCE

BT PAIN RELIEF 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.06 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)
INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)
MYRRH (UNII: JC71GJ1F3L)
FRANKINCENSE (UNII: R9XLF1R1WM)
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SESAME OIL (UNII: QX10HYY4QV)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
YELLOW WAX (UNII: 2ZA36H0S2V)
ZINC OXIDE (UNII: SOI2LOH54Z)

Product Characteristics
Color	green	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0011-1	3 in 1 BAG	01/01/2024
1		5.9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2024

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.		656348265	manufacture(82198-0011) , label(82198-0011) , pack(82198-0011)