BIOFREEZE PROFESSIONAL- menthol, unspecified form gel 
NuCare Pharmaceuticals,Inc.

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 Professional Gel

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 arthiritis, backache, strains and sprains

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

Sensitive skin

When using this product:

Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniment; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in cool dry place

Stop use and ask a doctor If:

Condition worsens, or if symptoms persist for more than 7 days , or clear up and recur

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 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or Comments:

1-800-246-3733

Package Labeling:

PDP

BIOFREEZE PROFESSIONAL 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4325(NDC:59316-115)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4325-4120 mL in 1 TUBE; Type 0: Not a Combination Product03/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/03/2016
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-4325)

Revised: 2/2021
Document Id: bb7a49fa-9289-39d3-e053-2995a90a8359
Set id: 66ff9726-20da-688a-e053-2a91aa0a59ac
Version: 5
Effective Time: 20210216
 
NuCare Pharmaceuticals,Inc.