BT PAIN RELIEF- menthol, methyl salicylate spray

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-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 10%

Methyl Salicylate 5%

Purpose

External analgesic

Uses

For temporary relief of joint and muscles aches and pains

• sprains and strains
• inflammation
• mild bruises

Warnings

For external use only

• Use only as directed
• Avoid contact with the eyes or mucous membranes
• Do not use on open wounds or irritated or broken skin.
• Discontinue use if skin rash or irritation develops or if condition worsens.
• Consult your doctor before use if you are pregnant or breast feeding.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Clean and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.

Other Information

• Store at room temperature
• Shake well before use, close cap tightly after use
• Read all product information before use

Inactive Ingredients

Cinnamomum kanehirae Hayata Essential Oil, Saposhnikoviae Radix, Artemisia Argyi Folium, Moutan Cortex, Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Paeoniae Radix, Rubra Notoginseng Radix et Rhizoma, Carthami Flos, Alcohol.

Questions or Comments?

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SPL UNCLASSIFIED SECTION

Distributed by

Big 5 Nutrition LLC

Made in Taiwan

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BT PAIN RELIEF 
menthol, methyl salicylate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0012
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	100 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
SAFFLOWER (UNII: 4VBL71TY4Y)
ALCOHOL (UNII: 3K9958V90M)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)

Product Characteristics
Color	brown (Light Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0012-1	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2024

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.		656348265	manufacture(82198-0012) , label(82198-0012) , pack(82198-0012)