BIOFREEZE FLEXIBLE RELIEF STRIP- menthol patch 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biofreeze® Flexible Relief Strip

Drug Facts

Active ingredient

Menthol 5.6%

Purpose

Pain Relieving Patch

Uses

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

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

Other information

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

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

PRINCIPAL DISPLAY PANEL - 4 Strip Carton
BIOFREEZE FLEXIBLE RELIEF STRIP 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM56 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-004-011 in 1 POUCH03/31/2021
16 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:59316-004-044 in 1 CARTON03/31/2021
26 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/31/2021
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022
Document Id: cefc6ed9-1763-44cd-a74e-52a1b8b7d704
Set id: 6ec26bae-e395-49aa-969e-8c653d6f0b27
Version: 3
Effective Time: 20220120
 
RB Health (US) LLC