Biofreeze Professional Spray

Biofreeze Professional Spray

Drug Labeling and Warnings

Drug Details

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BIOFREEZE PROFESSIONAL- menthol, unspecified form spray 
Performance Health, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biofreeze Professional Spray

Drug Facts

Active Ingredients:

Menthol USP 10.5%

Purpose

Cooling Pain Relief

Uses:

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

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

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

Ask a doctor before use if you have:

Sensitive skin

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 liniment; 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 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 2 years of age and older: Spray on to the affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult physician

Inactive Ingredients:

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Questions or Comments:

1-800-246-3733

Package Labeling: 59316-120-30

Label4

Package Labeling: 59316-120-20

Label3

BIOFREEZE PROFESSIONAL 
menthol, unspecified form spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
JUNIPER BERRY (UNII: O84B5194RL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-120-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
2NDC: 59316-120-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/03/2016
Labeler - Performance Health, LLC (794324061)

Revised: 10/2019
 
Performance Health, LLC


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