BIOFREEZE- 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

Drug Facts

Active Ingredients

Menthol 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 occur within a few days

If pregnant or breast-feeding:

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, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected 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

Package Labeling: 59316-993-07

Label5

Package Labeling: 59316-993-09

Label6

Package Labeling: 59316-993-08

PackagePackage2

BIOFREEZE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-993
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-993-071 in 1 POUCH01/30/201912/31/2024
11 in 1 PACKET
19 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:59316-993-095 in 1 CARTON01/30/201912/31/2024
21 in 1 POUCH
29 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:59316-993-0812 in 1 CARTON02/04/202112/31/2024
31 in 1 POUCH
39 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 finalpart34801/30/201912/31/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2021
Document Id: 21bb2f06-3d7b-43e3-865f-d9e50ac82e51
Set id: b523fe83-23f8-4aa2-9796-05fc52c1cc54
Version: 7
Effective Time: 20211220
 
RB Health (US) LLC