Label: BLUE ICE- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 1, 2015

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  • SPL UNCLASSIFIED SECTION

    Diva Blue Ice is a cool, greaseless pain reliever. It penetrates deep into skin for fast, temporary relief of minor aches and pains in muscles and joints. It provides cooling, soothing relief that lasts for hours.

  • Drug Facts

  • Active Ingredients

    Menthol 2%

  • Purpose

    Topical Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Usage:

    Provides temporary relief of minor aches and pains in muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.

  • Warning

    For External use only. Not for internal use.

    Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams, ointments, sprays or liniment. Do not bandage.

    Do not use with heating pads or heating devices.

    If condition worsens of symptoms persist for more than 7 days or if symptoms disappear and occur again within a few days, discontinue use and consult a physician. If you have sensitive skin, consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use.

  • Direction

    Clean skin of all other lotions, cream ointments, liniment or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years of age.

  • Inactive Ingredients:

    Water, Isopropyl Alcohol, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, Blue 1 (CI 42090).

  • STORAGE AND HANDLING

    Do not use, store, pour or spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

  • Distributed by

    JMD ALL STAR IMPEX INC.,

    Edison, NJ - 08817

    Made in India.

    Neutral Code : GUJ/GA/1676

  • Packaging

    blueicelbl

  • INGREDIENTS AND APPEARANCE
    BLUE ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69859-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69859-002-76227 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/23/2015
    Labeler - JT Cosmetics and Chemicals (650884849)
    Establishment
    NameAddressID/FEIBusiness Operations
    JT Cosmetics and Chemicals650884849manufacture(69859-002)
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