BIOFREEZE FLEXIBLE RELIEF STRIP- menthol patch

Biofreeze Flexible Relief Strip by

Drug Labeling and Warnings

Biofreeze Flexible Relief Strip 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 5.6%

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.
• do not stretch the patch during application as it should be comfortable and not tight
• do not overwrap or wrap patches over themselves
• for best adhesion: area should be clean, dry, and smooth
• 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, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water

Questions or comments?

1-800-246-3733

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 Strip Carton

CLINICALLY
RECOMMENDED*

NDC: 59316-004-04

BiOFREEZE®
COOL THE PAIN

FLEXIBLE
RELIEF
STRIPS
MENTHOL-PAIN
RELIEVING PATCH

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

Strong adhesion to stay
through any movement

Optimal thickness for
comfort and flexiblity

4 STRIPS |
EXTRA
LONG

10 in x 2 in
(25.4 cm x 5 cm) each

INGREDIENTS AND APPEARANCE

BIOFREEZE FLEXIBLE RELIEF STRIP 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-004
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	56 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
FRANKINCENSE (UNII: R9XLF1R1WM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)
MINERAL OIL (UNII: T5L8T28FGP)
NONOXYNOL-10 (UNII: K7O76887AP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-004-01	1 in 1 POUCH	03/31/2021
1		6 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 59316-004-04	4 in 1 CARTON	03/31/2021
2		6 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	03/31/2021

Labeler - RB Health (US) LLC (081049410)