Label: PERSONAL CARE ICE COLD- 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 August 25, 2011

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active ingredients                        Purpose

    Menthol (1%)................................Topical Analgesic

  • PURPOSE

    Uses-For the temporary relief of minor aches and pains in muscles and joints associated with:

    simple backache

    sports injuries

    strains

    arthritis

    sprains

    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 clear up and occur again within a few days

    redness or irritation develops

  • INDICATIONS & USAGE

    For the temporary relief of aches and pains in muscles and joints associated with

    simple backache

    sports injuries

    strains

    arthritis

    sprains

    bruises


  • 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.

  • 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: carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water(aqua), FDandC blue no 1

  • PRINCIPAL DISPLAY PANEL

    analgesicbacklabel
  • PRINCIPAL DISPLAY PANEL

    DISTRIBUTED BY PERSONAL CARE PRODUCTS INC

    Bingham Farms MI 48025-2463 USA

    Made in China

    Personal Care Ice Cold Analgesic Gel

    Net wt. 8oz (227g)

  • PRINCIPAL DISPLAY PANEL

    gellabelpdp

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE ICE COLD  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2278
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2278-1227 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34806/04/2010
    Labeler - Personal Care Products, Inc. (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan daily Chem. Products Co Ltd530766098manufacture
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