Label: BLUE ICE ANALGESIC GEL- menthol gel

  • NDC Code(s): 15127-452-08
  • Packager: Select Brand Distributors
  • 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 October 7, 2014

If you are a consumer or patient please visit this version.

  • Active Ingredient


    Menthol 2.0%

  • Uses

    • Temporary relief of minor aches and pains in: muscles and joints.
  • Directions

    Directions:

    • See important warnings under ''When Using This Product''.
    • Do not apply to children under 2 years of age, unless advised by a physician.
    • Adults and children over 2 years of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.
  • Warnings

    • For external use only.
    • Avoid contact with eyes and mucus membranes.

    When using this product, do not:

    • use with heating pads or heating devices
    • use, pour, spill or store near open flame
    • use with other creams, sprays or liniments
    • apply to damaged skin or wounds
    • bandage area tightly

    To do so may result in excessive skin irritation or skin burn.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

  • PRINCIPAL DISPLAY PANEL

    SB Blue Ice Gel

  • Purpose

    • Analgesic.
  • INACTIVE INGREDIENTS

    INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

  • Keep out of reach of children

    • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
  • INGREDIENTS AND APPEARANCE
    BLUE ICE ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-452
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 88.05 g  in 100 g
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 8.91 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.667 g  in 100 g
    THYMOL (UNII: 3J50XA376E) 0.2 g  in 100 g
    AMMONIA (UNII: 5138Q19F1X) 0.06 g  in 100 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.1 g  in 100 g
    MAGNESIUM SULFATE (UNII: DE08037SAB) 0.01 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.003 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-452-08227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/06/2014
    Labeler - Select Brand Distributors (043562370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delon Laboratories (1990) Ltd243387722label(15127-452) , manufacture(15127-452) , pack(15127-452)