Label: BL3 MINERAL ICE GEL- menthol gel

  • 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 June 14, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 2%

  • PURPOSE

    Menthol 2% .........................Analgesic

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings

    For external use only

    • sue only as directed

    • avoid contact with eyes

    • do not bandage tightly

    • do not apply to wounds or damaged skin

    •​ do not use with heating pad

  • STOP USE

    Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Direction

    • For adult & children 2 years of age and older

    • Cleans ad dry skin

    • Apply to affected area not more than 3 to 4 times daily

    • may be used with wet or dry bandages in conjunction with ice packs

    • children under 2 years of age, consult a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients Ammonium Hydroxide, Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl Alcohol, Magnesium Sulfate, Sodium Hydroxide, Thymol, Water.

  • PRINCIPAL DISPLAY PANEL

    BL3 Ice Gel

  • INGREDIENTS AND APPEARANCE
    BL3 MINERAL ICE GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    THYMOL (UNII: 3J50XA376E)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRAETHYLAMMONIUM HYDROXIDE HEXAHYDRATE (UNII: 2GBD78DRH6)  
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-013-01227 g in 1 JAR; Type 0: Not a Combination Product06/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/12/2019
    Labeler - Inspec Solutions, LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions, LLC.081030372manufacture(72667-013)
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