BIOFREEZE PATCH MULTI PACK- menthol kit

Biofreeze Patch Multi Pack by

Drug Labeling and Warnings

Biofreeze Patch Multi Pack 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 USP 5%

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:

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 in a cool dry place 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 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: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while areas not more than 4 times daily. Wash hands with cool water after use
Children under 12 years of age: Consult physician

Inactive Ingredients: 

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions or Comments:

1-800-246-3733

69316-889-04

59316-993-32

Package Labeling: 59316-993-33

INGREDIENTS AND APPEARANCE

BIOFREEZE PATCH MULTI PACK 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-889

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-889-04	1 in 1 KIT	01/30/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PATCH	40 g  in 2
Part 2	2 PATCH	26 g  in 2

Part 1 of 2

BIOFREEZE 
menthol patch

Product Information
Item Code (Source)	NDC: 59316-993
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-993-32	1 in 1 POUCH
1		20 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2019

Part 2 of 2

BIOFREEZE 
menthol patch

Product Information
Item Code (Source)	NDC: 59316-993
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-993-33	1 in 1 POUCH
1		13 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2019

Labeler - Performance Health, LLC (794324061)