Label: ELIZABETH HEALTH STYLE ICE COLD (camphor- synthetic, levomenthol gel

  • NDC Code(s): 80591-002-01
  • Packager: AYUSHREE PHARMACEUTICALS PRIVATE LIMITED
  • 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 July 28, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient                            Purpose

    Menthol 2.50% .......................... Topical analgesic

    Camphor 0.5 % ......................... Topical analgesic

  • PURPOSE

  • Use

    for the temporary relief of minor aches and pains in muscle and joints 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

    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

    • Conditions worsens symptoms last more than 7 days or clear up and occur again within a few days
    • redness or irritation develop

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean affected area before applying product

          adults and children 2 year of age and older: apply to affected area

    • not more than 3 to 4 times daily.
  • Inactive ingredients

    Carbomer 940, Color: FD&C Blue No.1, lsopropyl Alcohol, Methyl Chloroisothiazolinone, Methyl lsothiazolinone, Propylene Glycol, Purified Water, Triethanolamine.

    Questions? ca11 305-627-3116

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    ELIZABETH HEALTH STYLE ICE COLD 
    camphor (synthetic), levomenthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80591-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.5 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80591-002-01227 g in 1 DRUM; Type 0: Not a Combination Product09/28/202002/28/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/28/202002/28/2024
    Labeler - AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (861375952)
    Establishment
    NameAddressID/FEIBusiness Operations
    AYUSHREE PHARMACEUTICALS PRIVATE LIMITED861375952manufacture(80591-002)