FDA.reportPublic FDA data

BT Pain Relief Spray

Manufacturer
Big 5 Nutrition LLC | TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.
Effective date
2023-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:15

Label at a glance#

ProductBT Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure11 sections

Indications and uses

For temporary relief of joint and muscles aches and pains sprains and strains inflammation mild bruises

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl Salicylate 5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of joint and muscles aches and pains

  • sprains and strains
  • inflammation
  • mild bruises

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

Distributed by

Big 5 Nutrition LLC

Made in Taiwan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1875611menthol 10 % / methyl salicylate 5 % Topical SprayPSN1
1875611menthol 100 MG/ML / methyl salicylate 50 MG/ML Topical SpraySCD1
1875611menthol 10 % / methyl salicylate 5 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0012-1BT Pain Relief70 mL in 1 BOTTLESPRAY701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0012BT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) SPRAY [BIG 5 NUTRITION LLC]1Current NDC, 1 package rows20240101_91324910-27cf-424f-9e9b-6173f2d7acbf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82198-001282198-0012-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
PANAX NOTOGINSENG ROOTGQX1C1175UIACT
SAFFLOWER4VBL71TY4YIACT
ALCOHOL3K9958V90MIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
SAPOSHNIKOVIA DIVARICATA ROOT8H84LFK2QDIACT
ARTEMISIA ARGYI LEAF2JYC99Q0WZIACT
PAEONIA X SUFFRUTICOSA ROOT BARKBUG255FE7XIACT
ACTAEA CIMICIFUGA ROOT65J267BAZTIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC91324910-27cf-424f-9e9b-6173f2d7acbf2023-11-21WarningsExact identifier
ndc (package): 82198-0012-1
ndc (product): 82198-0012
ndc11 (package): 82198001201
spl id: 0aa61368-2851-7dba-e063-6394a90af0ee
spl set id: 91324910-27cf-424f-9e9b-6173f2d7acbf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.