Label: ICE COLD ANALGESIC- menthol,camphor 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 November 9, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol             1%

    Camphor          0.5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

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

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

    Warnings

    For external use only

  • DO NOT USE

    Do not use

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

    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

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clean up and occur again within a few days
    • redness or irritation develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    If swallowed, get medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Inactive Ingredients

    benzyl alcohol, butylated hydroxy toluene, carbopol, color brilient blue, creasmer RH-40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ICE COLD ANALGESIC GEL

    Topical Analgesic

    NET WT.8 OZ (227g)

    label

  • INGREDIENTS AND APPEARANCE
    ICE COLD ANALGESIC 
    menthol,camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70201-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    BRILLANT BLUE (UNII: 1Y6J4O88C8)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70201-003-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/03/2015
    Labeler - North & South Wholesalers LLC (004948495)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(70201-003)
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