Label: THERACARE ICE BLUE GEL 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 May 24, 2023

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  • Active ingredient

    Menthol 2%

  • 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

  • When Using this product

    • with other topical pain relievers
    • with heating pads or heating devices
    • avoid contact with eyes
    • do not bandage tightly
    • do not apply to wounds or damage skin
  • Stop use and ask a doctor if

    • condition worsens or 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 (800-222-1222) 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 before using this product
  • Other information

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

    ammonium hydroxide, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

  • Questions or comments?

    Customer care 866-326-1313

  • Principal Display

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE ICE BLUE GEL  PAIN RELIEVING
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-217-01226.8 g in 1 JAR; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2022
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-217)
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