BT PAIN RELIEF- menthol, methyl salicylate patch 
Big 5 Nutrition LLC

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BT Pain Relief Patch

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 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 or comments?

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Distributed by

Big 5 Nutrition LLC

Made in Taiwan

Packaging

LABEL

BT PAIN RELIEF 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.06 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82198-0011-13 in 1 BAG01/01/2024
15.9 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)01/01/2024
Labeler - Big 5 Nutrition LLC (114574559)
Establishment
NameAddressID/FEIBusiness Operations
Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.656348265manufacture(82198-0011) , label(82198-0011) , pack(82198-0011)

Revised: 11/2023
Document Id: 0ab7cd72-6a18-d846-e063-6294a90aa6ff
Set id: 251a133e-73ac-4d0e-bce7-30dcfc6b0de6
Version: 1
Effective Time: 20231122
 
Big 5 Nutrition LLC