FDA.reportPublic FDA data

Biofreeze Triple Target ® Gel

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:52

Label at a glance#

ProductBiofreeze Triple Target Gel
Active ingredientCAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure11 sections

Indications and uses

Uses Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 12 years of age: consult a physician wash hands after use with cool water

Storage and handling

store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 6%
Capsaicin 0.05%
Menthol 10%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and

pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Alcohol, Caprylyl Glycol, Carbomer,
Denatonium Benzoate, Ethylhexylglycerin, Glycerin,
Menthyl Ethylamido Oxalate, Phenoxyethanol,
Propanediol, Purified Water, Steareth-2,
Steareth-21, T-Butyl Alcohol, Tetrasodium
Glutamate Diacetate, Trolamine

Questions or comments?

OTC - QUESTIONS SECTION

1-866-682-4639

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2741687camphor 6 % / capsaicin 0.05 % / menthol 10 % Topical GelPSN2
2741687camphor 0.06 MG/MG / capsaicin 0.0005 MG/MG / menthol 0.1 MG/MG Topical GelSCD2
2741687camphor 6 % / capsaicin 0.05 % / menthol 10 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130731124444912GTIN-13: 0731124444912
EAN-13: 0731124444912
GTIN-12: 731124444912
UPC-A: 731124444912
GTIN storage (14 digits): 00731124444912		59316-122 label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-122-33BiofreezeTriple Target Gel89 mL in 1 BOTTLEGEL892
59316-122-33BiofreezeTriple Target Gel1 in 1 CARTONGEL12

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-12259316-122-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
CARBOMER0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARETH-2V56DFE46J5IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
STEARETH-2153J3F32P58IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPSAICINS07O44R1ZMACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
MENTHYL ETHYLAMIDO OXALATEG2MB8B7PSMIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
T-BUTYL ALCOHOLMD83SFE959IACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPANEDIOL5965N8W85TIACT

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
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
ndc (package): 59316-122-33
ndc (product): 59316-122
ndc11 (package): 59316012233
spl id: 511848da-e35d-2343-e063-6294a90ae321
spl set id: 511852c8-7428-3234-e063-6394a90a5bc2

Reported adverse events (FAERS/openFDA)#

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