Label: PERSONAL CARE EXTRA STRENGTH COLD HOT- menthol patch

  • 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 September 28, 2012

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                    Purpose

    Menthol 5% ..........................................................................Topical analgesic

  • PURPOSE

    Uses for the temporary relief of minor aches and pains associated with:

    • simple backache
    • muscle strains
    • muscle sprains
    • cramps
    • bursitis
    • arthritis
    • bruises
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING


    When using this product

    • use only as directed
    • do not apply to wounds, damaged, or sensitive skin
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
  • STOP USE

    Stop use and ask doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin 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 reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Directions

    adults and children 12 years of age and older

    • partially peel back protective film and apply exposed patch to site of pain
    • carefully remove remaining film while pressing patch to skin for secure adhesion
    • repeat as necessary, but not more than 3 to 4 times daily
    children under 12 years of age consult a doctor
  • STORAGE AND HANDLING

    Other information

    Store at 68o to 77oF (20o to 25oC)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monsterarate, polysorbate 80,

    polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate (Vitamin E).

  • DOSAGE & ADMINISTRATION

    Distributed by:

    PERSONAL CARE PRODUCTS, LLC.

    Bingham Farms, MI 48025-3463

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE EXTRA STRENGTH COLD HOT  
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINOMETASILICATE TYPE I-A (UNII: 7LVU907546)  
    PEG-120 Stearate (UNII: 0V73PIX5YC)  
    povidone K90 (UNII: RDH86HJV5Z)  
    sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J)  
    tartaric acid (UNII: W4888I119H)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9083-31 in 1 CARTON
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/20/2011
    Labeler - PERSONAL CARE PRODUCTS, LLC (966155082)
    Registrant - UNITED EXCHANGE CORP (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD528194366manufacture(29500-9083)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yongkang Bangli Medical Products Co Ltd723738741manufacture(29500-9083)