BIOFREEZE FOOT CREAM- menthol cream

Biofreeze Foot Cream by

Drug Labeling and Warnings

Biofreeze Foot Cream by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 10%

Purpose

Pain Relieving Cream

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

When using this product

• use only as directed
• avoid contact with the eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
• children under 12 years of age: consult a physician
• wash hands after use with cool water

Other information

• store at 20-25°C (68-77°F)
• store in a cool dry place away from direct sunlight

Inactive ingredients

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, 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

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label

CLINICALLY
RECOMMENDED*

NDC: 59316-001-20

BiOFREEZE®
COOL THE PAIN

FOOT CREAM

MENTHOL-PAIN
RELIEVING CREAM

Net wt 4 OZ (113.3 g)

INGREDIENTS AND APPEARANCE

BIOFREEZE FOOT CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-001-10	85 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2021
2	NDC: 59316-001-20	113.3 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/12/2021

Labeler - RB Health (US) LLC (081049410)