BIOFREEZE

BIOFREEZE

Drug Labeling and Warnings

Drug Details

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BIOFREEZE- menthol gel 
Performance Health LLC
Reference Label Set Id: a85cbb9e-64cb-47e1-bf20-f0af58e77c75

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

Active Ingredients


Menthol USP 4%

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

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 liniments
  • Do not apply to irritated skin or if excessive irritated develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device

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 than 4 times daily; massage not necessary
  • Children under 2 years of age: Consult physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Carbomer, Camellia Sinensis Leaf Extract , Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract (Green Tea), Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamine E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5

Questions or Comments

 1-800-246-3733

Representative Labeling

Package Label

BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-102-105 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
2NDC: 59316-102-113 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
3NDC: 59316-102-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/03/201212/31/2018
4NDC: 59316-102-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
5NDC: 59316-102-25118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/03/201212/31/2021
6NDC: 59316-102-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
7NDC: 59316-102-40946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
8NDC: 59316-102-503785 mL in 1 CONTAINER; Type 0: Not a Combination Product01/03/2012
9NDC: 59316-102-9830 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
10NDC: 59316-102-8044 mL in 1 TUBE; Type 0: Not a Combination Product11/02/2018
11NDC: 59316-102-1289 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
12NDC: 59316-102-1689 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/19/201612/31/2019
13NDC: 59316-102-28237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/03/2012
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(59316-102)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC825646862manufacture(59316-102)

Revised: 10/2019
 
Performance Health LLC


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