Label: HOT ICE SOOTHING ANALGESIC- camphor and menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 31, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients   

    Menthol 1%

    Camphor 0.5%   

  • Purpose

    Topical analgesic

  • Uses   

    for the temporary relief of minor aches and pains in muscles and joins associated with

    • simple backache
    • strains
    • sprains
    • sports injuries
    • arthritis
    • bruises
  • Warnings

    For external use only.

    Do not use

    • with other topical pain relievers
    • with heating pads or heating devices

    When using this product

    • do not use in or near eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask doctor if

    • condition worsen
    • symptoms last more than 7 days or clear up and occurs again with a few days
    • redness or irritation develops

    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 way.

  • 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. 
  • Inactive ingredients

    Benzyl alcohol, butylated hyderoxy toluene, carbopol, colour brilliant blue, creasmer RH 40, disodium Edta, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide

  • Principal Display Panel

    FamilyCare
    ICE
    COLD
    ANALGESIC GEL
    NET WT. 8 OZ. (227 g)

    Principal Display Panel FamilyCare ICE COLD ANALGESIC GEL

  • INGREDIENTS AND APPEARANCE
    HOT ICE SOOTHING ANALGESIC 
    camphor and menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52271-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.14 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 934 (UNII: Z135WT9208)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52271-159-00227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/21/2009
    Labeler - Quality Care Distributors LLC (961937112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425MANUFACTURE
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