Label: PURE-AID BLUE ICE GEL- 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 July 20, 2022

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  • ACTIVE INGREDIENT

    Menthol 1.25%

  • PURPOSE

    Topical analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    For external use only

  • Do not use

    • Do not use with other topical pain relievers
    • Do not use with heating pads or other heating devices
  • When using this product

    • do not use in or near the eyes
    • 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 day or clear up and occur again withing a few days
  • If pregnant or breastfeeding

    Ask a health professional before use

  • Keep out of reach of children

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

  • Directions

    • Clean affected area before applying product
    • Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily
    • Children under 2 years of age: ask a doctor before using this product
  • Other Information

    • Store at 20ºC-25ºC (68º-77ºF) in a tightly closed container
    • store in a cool place
    • do not use, pour, spill or store near heat or open flame
  • Inactive Ingredients

    carbomer, camphor, FD&C blue no.1, isopropyl alcohol, methylchoroisothiazolinone, methylsothiazolinone, purified water, sodium hydroxide

  • Pure-Aid Blue Ice Gel

    label

  • INGREDIENTS AND APPEARANCE
    PURE-AID BLUE ICE GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0671
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0671-8226.8 g in 1 JAR; Type 0: Not a Combination Product07/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/20/2022
    Labeler - Kareway Product, Inc.` (121840057)
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