Label: ICE ANALGESIC- menthol 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 May 5, 2015

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  • ICE ANALGESIC GEL


  • Active Ingredient

    Menthol 1.0%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief:

    minor muscles aches and pains

  • Warnings


    For external use only. Avoid contact with eyes.

    Ask a doctor before use if you have cough associated with

    • smoking
    • excessive phlegm
    • asthma
    • emphysema
    • persistent or chronic cough
  • When using this product do not

    • heat
    • microwave
    • add to hot water or any container where healing water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin
  • Consult a doctor and discontinue use

    if condition worsens, persist for more than 1 week or tends to recur

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    For the temporary relief of minor muscle aches and pains

    see important warnings under "When using this product"

    • not for use on children under 2 years of age
    • adults and children 2 years of age and older: apply to painful area and massage until gel is absorbed into the skin, repeat 3 to 4 times daily
  • Inactive Ingredients

    blue 1, camphor, carbomer, isopropyl alcohol, methylchoroisothiazolinone, methuylisothiazoline, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    ICE Analgesic Gel

    Net wt 8oz (227g)

    DISTRIBUTED BY:

    Filo America

    P.O. Box 23592

    Los  Angeles, CA 90023

    Developed in USA, products in PRC

    questions or concerns?

    1.866.460.0322

  • ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)

    ICECOLD

  • INGREDIENTS AND APPEARANCE
    ICE ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-501-01227 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2015
    Labeler - Filo America (943873703)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-501)
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