Drug Facts

Active Ingredients:

Menthol USP 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 four times daily; massage not necessary
• Children under 12 years of age:Consult physician

Inactive Ingredients:

Caprylic/Capric Triglyceride, Caprylyl Glycol, Alcohol, Dimethicone, Gluconolactone Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water,Calcium Gluconate, Cetostearyl Alcohol, Edetate Sodium, Isopropyl Alcohol, PEG-4 Laurate

Questions or Comments:

1-800-246-3733

Package Labeling:

Label

BIOFREEZE
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-869
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-869-10	85 g in 1 JAR; Type 0: Not a Combination Product	03/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	03/21/2020

Labeler - RB Health (US) LLC (081049410)

Biofreeze Cream