Drug Facts

Active ingredient

Menthol 5%

Purpose

Pain Relieving Patch

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: 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 pressing the patch to skin and leave in place for up to 8 hours. Use on 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

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Cellulose Gum, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Phenoxyethanol, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions or comments?

1-800-246-3733

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

PRINCIPAL DISPLAY PANEL - Kit Carton

CLINICALLY
RECOMMENDED*

NDC 59316-887-04

BiOFREEZE®
COOL THE PAIN

EXTRA LARGE
PATCHES

MENTHOL-PAIN
RELIEVING PATCH

Designed to provide up to
8 hours of long lasting pain relief

Proven cold therapy formula for sore
muscles, simple backaches, and joint pain

Flexible fabric for superior performance and comfort

4 PATCHES | 2 SIZES
EXTRA LARGE
AND LONG

2 EXTRA LARGE 9.84 in x 5.5 in (25 cm x 14 cm) each
2 LONG 7.87 in x 3.94 in (20 cm x 10 cm) each

BIOFREEZE MENTHOL
menthol, unspecified form kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-887

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-887-04	1 in 1 KIT	03/10/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PATCH	20 g
Part 2	1 PATCH	13 g

Part 1 of 2

BIOFREEZE MENTHOL
menthol, unspecified form patch

Product Information
Item Code (Source)	NDC:59316-992
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	0.05 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
Carboxymethylcellulose sodium, unspecified (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
KAOLIN (UNII: 24H4NWX5CO)
Mineral Oil (UNII: T5L8T28FGP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Petrolatum (UNII: 4T6H12BN9U)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
Polysorbate 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:59316-992-32	1 in 1 POUCH
1		20 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/10/2022

Part 2 of 2