Label: BLUE ICE ANALGESIC- menthol gel

  • NDC Code(s): 61734-021-01, 61734-021-02, 61734-021-03
  • Packager: Delon Laboratories (1990) Ltd
  • 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 1, 2021

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  • Active ingredient


    Menthol 2.0%

  • Purpose

    Topical analgesic

  • Uses

    • for the temporarily relief of minor aches and pains of muscles and joints

  • Warnings

    For external use only

    When using this product

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

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    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

    • 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: consult a doctor
  • Inactive ingredients

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

  • Delon 8oz (227g)

    Delon Blue Ice Gel 8 oz

  • Penetro 227g

    Penetro Blue Ice Analgesic Gel 227 g

  • INGREDIENTS AND APPEARANCE
    BLUE ICE ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61734-021
    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)  
    AMMONIA (UNII: 5138Q19F1X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    CARBOMER 934 (UNII: Z135WT9208)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61734-021-01100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/07/201011/06/2017
    2NDC:61734-021-02113.56 g in 1 CONTAINER; Type 0: Not a Combination Product05/07/201012/04/2014
    3NDC:61734-021-03227 g in 1 CONTAINER; Type 0: Not a Combination Product05/07/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/07/2010
    Labeler - Delon Laboratories (1990) Ltd (248364184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delon Laboratories (1990) Inc.243387722manufacture(61734-021) , pack(61734-021) , label(61734-021)