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Biofreeze Professional Colorless

Dosage form: gel
Ingredients: MENTHOL, UNSPECIFIED FORM 50mg in 1mL
Labeler: Performance Health, LLC
NDC Code: 59316-116

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 Colorless Gel

Drug Facts

Active Ingredients:

Menthol USP 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: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water.

Questions or Comments:

1-800-246-3733

Package Labeling:

BIOFREEZE PROFESSIONAL COLORLESS 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-116
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARCTIUM LAPPA ROOT 
ARNICA MONTANA FLOWER 
FRANKINCENSE 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
CARBOXYPOLYMETHYLENE 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
MELISSA OFFICINALIS LEAF 
SILICON DIOXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-116-113 mL in 1 PACKET
2NDC:59316-116-20118 mL in 1 TUBE
3NDC:59316-116-40946 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)

Revised: 06/2016
 
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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