Biofreeze Colorless Gel

Biofreeze Colorless Gel

Drug Labeling and Warnings

Drug Details

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BIOFREEZE COLORLESS- menthol gel 
Performance Health LLC
Reference Label Set Id: 27dbe7b7-8f56-41e6-93a0-4581d2dfb451

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 Colorless Gel

Drug Facts

Active Ingredients


Menthol 4%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles & 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
  • Store in a 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 reoccur

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

Inactive Ingredients:

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

Questions or Comments

1-800-246-3733

Package Labeling: 59316-103-40

Label

Package Labeling: 59316-103-20

Label2

BIOFREEZE COLORLESS 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-103
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-103-40946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
2NDC: 59316-103-105 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/201212/31/2014
3NDC: 59316-103-113 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/201212/31/2021
4NDC: 59316-103-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/03/201212/31/2018
5NDC: 59316-103-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
6NDC: 59316-103-1289 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
7NDC: 59316-103-28273 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/201612/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/03/2012
Labeler - Performance Health LLC (794324061)

Revised: 10/2019
 
Performance Health LLC


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