Label: BIOEASE PAIN RELIEVING COLD THERAPY- menthol, camphor gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated February 2, 2014

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  • Active ingredient

    Menthol USP……..3.5%
    Camphor………….0.2%

  • Purpose

    Pain Relief

  • Uses

    Temporarily relieves minor aches and pains associated with • sore muscles and stiff joints • back pain • arthritis

  • Warnings

    For external use only

    When using this product: Use only as directed • Do not bandage or use a heating pad or device • Avoid contact with eyes and mucous membranes • Do not apply to open wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • After applying wash hands thoroughly with cool water

    Stop use and ask a doctor if: Condition worsens or symptoms persist for more than 7 days or clear up and recur • Redness is present or irritation develops

  • Pregnancy or Breast Feeding

    Ask a health professional before use

  • Keep Out of Reach of Children

    In case of accidental ingestion get medical help or contact a Poison Control Center immediately

  • Directions

    Adults and children 2 years of age and older: Apply directly onto affected area without the need to rub, massage or bandage • Repeat as necessary but do not apply more than 4 times daily.

    Children under 2 years of age: Consult a Physician

  • Storage and Handling

    Store in a cool dry place with lid or cap closed tightly

  • Inactive Ingredients

    Isopropanol, Ilex Paraguariensis, Carbomer, Triethanolamine, Methylparaben, Silicon Dioxide, Deionized Water, Propylene Glycol, Glycerin, FD&C Blue #1, FD&C Yellow #5

  • Package/Label Principal Display Panel

    Bioease Label
  • INGREDIENTS AND APPEARANCE
    BIOEASE PAIN RELIEVING COLD THERAPY 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL).2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68678-053-0395 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2014
    Labeler - AHC Ventures Corp DBA Cryoderm (131871779)
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