Label: BIOFLEXOR 04- menthol gel

  • NDC Code(s): 62391-100-02, 62391-100-04, 62391-100-30
  • Packager: Health Care Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • 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

    For external use only.

    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
  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • STORAGE AND HANDLING

    Store at 15º-30ºC (59º-86ºF)

  • 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 DOCTOR

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

  • WHEN USING

    When using this product:

    • avoid contact with the eyes or mucous membranes

    • do not bandage tightly

  • STOP USE

    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

  • PRINCIPAL DISPLAY PANEL

    Bioflexor

    Front Panel

  • INGREDIENTS AND APPEARANCE
    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)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    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
    2NDC:62391-100-0267.5 g in 1 JAR; Type 0: Not a Combination Product03/01/1998
    3NDC:62391-100-30960 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 DrugM01703/01/1998
    Labeler - Health Care Laboratories Inc. (088637298)
    Registrant - Health Care Laboratories Inc (088637298)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Care Laboratories Inc.088637298manufacture(62391-100)
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