BIOFREEZE- menthol spray 
RB Health (US) LLC

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Biofreeze Spray

Drug Facts


Active Ingredients:

Menthol 10.5%

Purpose:

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains

Warnings

For external use only.

Flammable:

Keep away from excessive heat or open flame.

Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F

Ask a Doctor Before using If You have:

■ 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

When Using This Product

Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniments; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in a cool dry place

Stop Use And Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions:

Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary
Children under 12 years of age:Consult physician

Inactive Ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis
Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita
(Matricaria) Flower Extract, Denatonium Benzoate, Echinacea
Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract,
Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis
Fruit Extract, Methylsulfonylmethane, Purified Water,
Tert-Butyl Alcohol

Questions or Comments:

1-800-246-3733

Package Labeling:

LabelLabel

BIOFREEZE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-833
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL105 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALCOHOL (UNII: 3K9958V90M)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
JUNIPER BERRY (UNII: O84B5194RL)  
WATER (UNII: 059QF0KO0R)  
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)  
TEA LEAF OIL (UNII: VC855RRT77)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-833-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/10/2023
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2023
 
RB Health (US) LLC