Label: BLUE ICE PAIN RELIEVING- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 17, 2015

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  • Active Ingredient

    Menthol

    Capsaicin

  • Purpose

    Pain Reliever

    Pain Reliever

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    ● arthritis ● simple backache ● strains

    ● bruises ● sprains

  • Warnings

    For external use only

    Do not use

    • with other topical pain relievers
    • with heating pads or heating devices

    When using this product

    • avoid contact with the eyes
    • use only as directed
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • redness or irritation develops

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean affected area before applying product
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other information

    • store at room temperature
    • keep lid tightly closed
    • do not use, pour, spill or store near heat or open flame
  • Inactive ingredients

    ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

  • Package label

    Maslac Blue IceMaslac Icy Blue Gel + Capsaicin

  • INGREDIENTS AND APPEARANCE
    BLUE ICE  PAIN RELIEVING
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69666-368
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.05 g  in 1 g
    capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin.00025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69666-368-081 in 1 BOX
    1227 g in 1 JAR
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/17/2015
    Labeler - Genuine Drugs (079610378)
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