BIOFREEZE FOAM- menthol liquid

Biofreeze Foam by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients:

Menthol 7%

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:

Use only as directed  Do not bandage tightly or use with heating pad or device Avoid contact with 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 Store at room temperature away from direct sunlight.

Stop use and ask a doctor if:

Burning discomfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur within a few days

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:

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

Package Labeling:

INGREDIENTS AND APPEARANCE

BIOFREEZE FOAM 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: ZEL54N6W95)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PPG-24-GLYCERETH-24 (UNII: V341SPY84U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-991-10	88 mL in 1 BOTTLE; 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)