Drug Facts

Active ingredient

Menthol 7%

Purpose

Pain Relieving Liquid

Uses

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

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

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 on to affected area not more than 3 to 4 times daily; massage not necessary
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

Alcohol Denat., Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Bis-PEG-10 Dimethicone, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydroxyethyl Cetyldimonium Phosphate, Ilex Paraguariensis Leaf Extract, Isopropyl Palmitate, Melissa Officinalis Leaf Extract, PEG-12 Dimethicone, Pentylene Glycol, PPG-24-Glycereth-24, Water

Questions or comments?

1-800-246-3733

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

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

CLINICALLY
RECOMMENDED

NDC 59316-991-10

BIOFREEZE®
COOL THE PAIN

FAST
DRY
FOAM

MENTHOL-PAIN
RELIEVING LIQUID

⊕: RUBS IN EASILY
⊕: LIGHTWEIGHT FEEL
⊕: DRIES QUICKLY

3 FL OZ (88 mL)

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

BIOFREEZE FOAM
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-991
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	70 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROXYETHYL CETYLDIMONIUM PHOSPHATE (UNII: 9G05UO431K)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PPG-24-GLYCERETH-24 (UNII: V341SPY84U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-991-10	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2020

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

Labeler - RB Health (US) LLC (081049410)

Biofreeze® Foam