Label: UNIVERSAL ICE COLD ANALGESIC- 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 December 13, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relieves of minor aches and pains in muscles and joints associated with

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

  • 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 the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • 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
  • If pregnant or breast-feeding,

    • ask a health professional before use
  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean affected area before applying products
    • adults and children 2 years of age and older
    • apply to affected area not more than 3 to 4 times daily.
  • Inactive ingredients

    Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

  • PRINCIPAL DISPLAY PANEL

    ICE COLD
    ANALGESIC GEL
    8 FL.OZ (237 ml)
    PRINCIPAL DISPLAY PANEL


  • INGREDIENTS AND APPEARANCE
    UNIVERSAL ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    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:47046-159-01237 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2020
    Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(47046-159)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!