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Biofreeze Professional by Performance Health, LLC

Medically reviewed on June 6, 2018

Dosage form: spray
Ingredients: MENTHOL, UNSPECIFIED FORM 105mg in 1mL
Labeler: Performance Health, LLC
NDC Code: 59316-120

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.

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

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:

BIOFREEZE PROFESSIONAL 
menthol, unspecified form spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-120
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM105 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ARNICA MONTANA FLOWER 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
CHAMOMILE 
DIMETHYL SULFONE 
ECHINACEA ANGUSTIFOLIA 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL MYRISTATE 
JUNIPER BERRY 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-120-30473 mL in 1 BOTTLE
2NDC:59316-120-20118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/03/2016
Labeler - Performance Health, LLC (794324061)

 
Performance Health, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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