Label: ICE COLD ANALGESIC GEL- menthol and camphor gel

  • NDC Code(s): 52000-013-13, 52000-013-14, 52000-013-15, 52000-013-16, view more
    52000-013-17, 52000-013-18
  • Packager: Universal Distribution Center LLC
  • 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 February 21, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol             1.0%

    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 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 hydroxytoluene, carbopol, colour brillient blue, creasmer RH 40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water and sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    ICE COLD ANALGESIC GEL

    Topical Analgesic
    NET WT.8 OZ (227g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    ICE COLD ANALGESIC GEL 
    menthol and camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-013
    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 934 (UNII: Z135WT9208)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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:52000-013-17127 g in 1 TUBE; Type 0: Not a Combination Product02/14/2022
    2NDC:52000-013-18170 g in 1 TUBE; Type 0: Not a Combination Product02/14/2022
    3NDC:52000-013-13170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    4NDC:52000-013-14227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    5NDC:52000-013-15300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    6NDC:52000-013-16500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/15/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-013)
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