FDA.reportPublic FDA data

BT Pain Relief Balm

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 00:06:13

Label at a glance#

ProductBT Pain Relief Balm
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, CAMPHOR, (-)-
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles due to: strains bruises sprains simple backache travel and motion sickness itching from insect and mosquito bites heat stroke and dizziness

Dosage and administration

​ Apply to the affected area. Rub well on affected area. Repeat a few times daily. ​​Children under 2 years of age: Do not use or consult a doctor

Storage and handling

Store unused products in the box Store at room temperature, 20 to 25 ​o ​C (68 to 77 ​o ​F)​​​

Label contents#

Full prescribing information#

​Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 20.7%
Menthol 15.6%
Camphor 3.1%

​Purpose

OTC - PURPOSE SECTION

External Analgesic   

​Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles due to:

  • strains
  • bruises
  • sprains
  • simple backache
  • travel and motion sickness
  • itching from insect and mosquito bites
  • heat stroke and dizziness

​Warnings

WARNINGS SECTION

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 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
  • redness is present • side effects occur.

If pregnant, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to 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

DOSAGE & ADMINISTRATION SECTION

  • ​Apply to the affected area. Rub well on affected area.
  • Repeat a few times daily.
  • ​​Children under 2 years of age: Do not use or consult a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Store unused products in the box
  • Store at room temperature, 20 to 25 ​o​C (68 to 77 ​o​F)​​​

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cinnamomum kanehirae Hayata Essential Oil, Eucalyptus oil, Lavender oil, Vaseline, White beeswax, FD&C Yellow No. 4

SPL UNCLASSIFIED SECTION

Distributed by:

Big 5 Nutrition LLC

Made in Taiwan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1990875camphor 3.1 % / menthol 15.6 % / methyl salicylate 20.7 % Topical OintmentPSN1
1990875camphor 0.031 MG/MG / menthol 0.156 MG/MG / methyl salicylate 0.207 MG/MG Topical OintmentSCD1
1990875camphor 3.1 % / menthol 15.6 % / methyl salicylate 20.7 % Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0010-1BT Pain Relief Balm35 g in 1 JAROINTMENT351
82198-0010-1BT Pain Relief Balm1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0010BT PAIN RELIEF BALM (METHYL SALICYLATE, MENTHOL, CAMPHOR) OINTMENT [BIG 5 NUTRITION LLC]1Current NDC, 2 package rows20240101_50112419-c934-4d3a-9ea6-9b089f516a6d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82198-001082198-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
PETROLATUM4T6H12BN9UIACT
WHITE WAX7G1J5DA97FIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR, (-)-213N3S8275ACTIB

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 Relief BalmMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLC50112419-c934-4d3a-9ea6-9b089f516a6d2023-11-21WarningsExact identifier
ndc (package): 82198-0010-1
ndc (product): 82198-0010
ndc11 (package): 82198001001
spl id: 0aa441d8-a293-a678-e063-6294a90a698e
spl set id: 50112419-c934-4d3a-9ea6-9b089f516a6d

Reported adverse events (FAERS/openFDA)#

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