Label: BIO-ICE- menthol, camphor gel

  • NDC Code(s): 50130-316-11
  • Packager: Electrostim Medical Services Inc. d/b/a EMSI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    MENTHOL 5.4%

    CAMPHOR 0.48%

  • PURPOSE

    PURPOSE

    TOPICAL ANALGESIC

    COUNTER IRRITANT

  • INDICATIONS & USAGE

    USES: TEMPORARY RELIEF OF

    • ARTHRITIS
    • BACKACHE
    • STRAINS
    • SPRAINS
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY.

  • DO NOT USE

    DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

    DO NOT USE WITH HEATING PADS OR DEVICES, OR UNDER BANDAGE.

    DO NOT USE IF PREGNANT OR BREAST FEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

    DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.
    • RUB IN THOROUGHLY UNTIL GEL IS ABSORBED.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT, HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT, BOSWELLIA SERRATA EXTRACT, CAMPHOR FOR SCENT.

  • PRINCIPAL DISPLAY PANEL

    Bio-Ice_LBL

  • INGREDIENTS AND APPEARANCE
    BIO-ICE 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50130-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.48 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50130-316-1188.8 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2013
    Labeler - Electrostim Medical Services Inc. d/b/a EMSI (932471881)
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