BIOFLEXOR 04- menthol gel 
Health Care Laboratories 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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BioFlexor Deep Penetrating Gel

ACTIVE INGREDIENT

Active Ingredient: Purpose:

Menthol 3% ……………………………………………………………………Topical Analgesic

Purpose

Topical analgesic

INACTIVE INGREDIENTS

Inactive Ingredients: Aloe Vera Juice, Butyl Paraben, Camphor USP, Carbopol Polymer, Edetate Disodium, Ethyl Paraben, Eucalyptus Oil, Isobutyl Paraben, Methyl Paraben, Peacock Blue MX26, 2-Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Propyl Paraben, Purified Water, Sodium Hydroxide, Yerba Mate, Yucca

WARNINGS SECTION

Warnings

For external use only.

Do Not Use:

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area.

When using this product:

• avoid contact with the eyes or mucous membranes

• do not bandage tightly

Stop use and ask a doctor if:

• condition worsens or symptoms persist for more than 7 days

• symptoms clear up and occur again within a few days

• excessive skin irritation occurs

Keep out of reach of children.

If swallowed, get medical help or contact the Poison Control Center right away.

Dosage and Administration

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: consult a doctor

PRODUCT DESCRIPTION

Description: BioFlexor® gel is an OTC topical analgesic preparation which delivers deep penetrating, effective pain relief. BioFlexor® is a unique product from several viewpoints. In developing BioFlexor®, our main focus was to formulate a potent topical analgesic agent that would minimize the need for oral narcotic analgesics. The result is an exceptional product that truly helps those individuals suffering from the pain associated with the spectrum of medical conditions from arthritis to muscle aches and pain, simple back aches, strains, bruises, and sprains.. Menthol is the only listed active ingredient on the BioFlexor® label. The other all natural components work synergistically to produce the pain relieving activity. Another unique aspect of BioFlexor® relates to the immediate and long-lasting pain relief without the side effects of lingering scent (Methyl Salicylate rubs, ie. Ben Gay), burning sensation (Capsaicin ie. Zostrix, Theragesic, Icy-Hot), greasy residue (ie. Aspercreme, Ben-Gay), and dry skin (alcohol formulations, ie. Biofreeze). The BioFlexor® formulation contains no alcohol, capsaicin, or methyl salicylate.

MECHANISM OF ACTION

Mechanism of Action: The initial pain relief mechanism produced by the absorption of BioFlexor® generates a topical cooling effect. This is a result of vasoconstriction of peripheral vessels in the affected areas, yielding a decreased blood flow. This action causes a decrease in temperature of the skin and subcutaneous tissues. As penetration continues, an interruption of sympathetic nerve conduction occurs, producing a warm vasodilation. This in turn increases the blood flow to muscle tissues and to the surface of the skin, promoting the healing process and rendering analgesic properties

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Store at 15º-30ºC (59º-86ºF)

PRINCIPAL DISPLAY PANEL

Bioflexor 4.5oz

BIOFLEXOR  04
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62391-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
ColorturquoiseScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62391-100-04135 g in 1 JAR; Type 0: Not a Combination Product03/01/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/1998
Labeler - Health Care Laboratories Inc. (088637298)
Registrant - Health Care Laboratories Inc (088637298)
Establishment
NameAddressID/FEIBusiness Operations
Health Care Laboratories Inc.088637298manufacture(62391-100)

Revised: 11/2021
 
Health Care Laboratories Inc.