BIOFREEZE TRIPLE TARGET ROLL-ON- camphor, capsaicin, menthol gel

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Camphor 6%
Capsaicin 0.05%
Menthol 10%

Purpose

Pain Relieving Gel

Uses

Uses

Temporarily relieves minor aches and

pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

• 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

• 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

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

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

Directions

• 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

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

Inactive ingredients

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?

1-866-682-4639

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

INGREDIENTS AND APPEARANCE

BIOFREEZE  TRIPLE TARGET ROLL-ON
camphor, capsaicin, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	60 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
CARBOMER (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-2 (UNII: V56DFE46J5)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-21 (UNII: 53J3F32P58)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MENTHYL ETHYLAMIDO OXALATE (UNII: G2MB8B7PSM)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
T-BUTYL ALCOHOL (UNII: MD83SFE959)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-208-33	1 in 1 CARTON	04/24/2026
1		74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/24/2026

Labeler - RB Health (US) LLC (081049410)