BIOFREEZE FOOT- menthol cream

Biofreeze Foot by

Drug Labeling and Warnings

Biofreeze Foot by is a Otc medication manufactured, distributed, or labeled by Performance Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Menthol 10%

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

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 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 breastfeeding:

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: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 12 years of age: Consult physician

Inactive Ingredients:

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone ,Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Questions or Comments:

1-800-246-3733

Package Labeling:

INGREDIENTS AND APPEARANCE

BIOFREEZE FOOT 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-990-20	113.3 g in 1 TUBE; Type 0: Not a Combination Product	01/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/27/2020

Labeler - Performance Health, LLC (794324061)