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Biofreeze by Performance Health LLC

Medically reviewed on September 19, 2018

Dosage form: gel
Ingredients: MENTHOL 40mg in 1mL
Labeler: Performance Health LLC
NDC Code: 59316-102

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 Gel

Drug Facts

Active Ingredients:

Menthol 4%

Purpose:

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - 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 liniments; Do not apply to irritated skin or if excessive irritated 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 2 years of age and older:

Rub a thin film over affected areas not more than 4 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, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or Comments

1-800-246-3733

Package Labeling:

BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARCTIUM LAPPA ROOT 
ARNICA MONTANA FLOWER 
FD&C BLUE NO. 1 
FRANKINCENSE 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
CARBOXYPOLYMETHYLENE 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
MELISSA OFFICINALIS LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:59316-102-1289 mL in 1 BOTTLE
2NDC:59316-102-1689 mL in 1 BOTTLE, WITH APPLICATOR
3NDC:59316-102-28237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/2016
Labeler - Performance Health LLC (794324061)

 
Performance Health LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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