Label: BIOFLEXOR- menthol gel

  • NDC Code(s): 62391-001-02, 62391-001-04, 62391-001-10, 62391-001-30
  • Packager: Health Care Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 21, 2014

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Apply BioFlexor gel onto the affected area(s) up to 3 to 4 times daily as needed.  Apply sufficient amount at bedtime for a restful sleep and in the morning to loosen stiff muscles and joints, and reduce pain.  The therapeutic effects of BioFlexor will allow you to become more active and return to normal activities of daily living.

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  • WARNINGS

    For External use only.  Do not swallow.  If Accidentally ingested, induce vomiting.  Call a physician or poison control center immediately.  If irritation develops, discontinue use of this product and consult a physician.  Do not use on open sores, wounds, irritated or broken skin.  Do not use with other creams, gels, ointments, topical medications, heating pads or other heat producing devices.  Avoid contact with eyes or mucous membrane.  Store in a cool dry place.  Keep out of reach of children to avoid accidental poisoning. BioFlexor gel is contraindicated in patients with a known hypersensitivity to menthol.  For children under 2, pregnant or nursing mothers, consult a physician



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  • HOW SUPPLIED

    0.25 oz (7.5 Gm) Jars NDC# 62391-001-10
    2.25 oz (67.5 Gm) Jars NDC# 62391-001-02
    4.5 oz (135 Gm) Jars NDC# 62391-001-04
    32 oz (960 Gm) Jars NDC# 62391-001-30

    TO PLACE ORDERS:
    To place orders, please call customer service at:
    1-800-909-9854
    Or Fax orders to:
    1-800-316-7853

    Visit our website at:
    www.bioflexor.com

    Mfg. by HEALTH CARE LABS, INC.
    P.O. Box 1734, Cleveland, TX 77328

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • PATIENT PACKAGE INSERT

    BioFlexor®
    Deep Penetrating
    Effective Pain Relief Gel

    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:  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.  BioFlexor® gel is contraindicated in patients with a known hypersensitivity to menthol.

    How Supplied:                                       
    2.25oz (67.5gm) Jars…..NDC# 62391-001-02                     
    4.5oz (135gm) Jars …..…NDC# 62391-001-04     

    TO PLACE ORDERS:
    Please call Customer Service at:   1-800-909-9854 
    or Fax Orders to:    1-800-316-7853
    or Visit our Website at:   www.bioflexor.com       

    Mfg. By: HEALTH CARE LABORATORIES, INC.               
    112 S. COLLEGE AVE. #100A
    CLEVELAND, TX 77327
    Store at controlled room temperature 15˚-30˚C (59˚-86˚F)    
     *Registered trademarks are the property of their respective owners.                

    DRUG FACTS
    Active Ingredient     Purpose
    Menthol 3%,           Topical Analgesic
    Uses 
    Temporarily relieves the minor aches and pains of muscles and joints associated with:
    •simple backache •arthritis •strains •bruises •sprains
    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.
    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
    Other Information
    • Store at 20°-25°C (68°-77°)
    • Lot No. and Expiration Date:  See Container
    Inactive Ingredients
    Carbopolymer, Edetate Disodium Peacock Blue MX26,
    Phenoxyethanol/Paraben Blend, Polysorbate 20, Potassium Sorbate,
    Proprietary Blend, Purified Water, Sodium Hydroxide

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  • ACTIVE INGREDIENT

    Active Ingredient:  Menthol 3%

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  • INACTIVE INGREDIENT

    Inactive Ingredients:  Carbopol Polymer, Edetate Disodium, Peacock Blue MX26, Phenoxyethanol/Paraben Blend, Polysorbate 20, Potassium Sorbate, Proprietary Blend, Purified Water, Sodium Hydroxide

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  • PURPOSE

    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.

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  • INDICATIONS & USAGE

    INDICATIONS: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

    USAGE:  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, pregnant or nursing mothers:  Consult a physician.

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  • BioFlexor Jar
  • INGREDIENTS AND APPEARANCE
    BIOFLEXOR 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62391-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.03 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62391-001-04 135 g in 1 JAR
    2 NDC:62391-001-02 67.5 g in 1 JAR
    3 NDC:62391-001-10 7.5 g in 1 JAR
    4 NDC:62391-001-30 960 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/01/1998
    Labeler - Health Care Laboratories Inc. (088637298)
    Establishment
    Name Address ID/FEI Business Operations
    Health Care Laboratories Inc. 088637298 manufacture(62391-001)
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