Label: COOL N HEAT PATCH FOR ARM, NECK AND LEG EXTRA STRENGTH- 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 October 10, 2013

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  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor pain associated with:

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

    Warnings

    • For external use only
    • If pregnant or breast-feeding, ask a health professional before use.
  • WHEN USING

    When using this product

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

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
  • 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
    adults and children 12 years of age and older

    • peel off protective backing and apply sticky side to affected area
    • carefully remove backing from patch
    • apply one patch to affected area
    • repeat as necessary, but no more than 4 times daily

    children under 12 years of age consult a doctor

  • STORAGE AND HANDLING

    Other information

    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

  • QUESTIONS

    Questions or comments? 1-800-WALGREENS (1-800-925-4733)

  • PRINCIPAL DISPLAY PANEL

    Image of box label

    Image of pouch label

  • INGREDIENTS AND APPEARANCE
    COOL N HEAT PATCH FOR ARM, NECK AND LEG  EXTRA STRENGTH
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol.05 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Gelatin (UNII: 2G86QN327L)  
    Kaolin (UNII: 24H4NWX5CO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Glycerin (UNII: PDC6A3C0OX)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Water (UNII: 059QF0KO0R)  
    PEG-4 Stearate (UNII: J33E8608YN)  
    Polyvinyl Alcohol (UNII: 532B59J990)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Silodrate (UNII: 9T3UU8T0QK)  
    Castor Oil (UNII: D5340Y2I9G)  
    Tartaric Acid (UNII: W4888I119H)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0150-015 in 1 BOX
    11 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/15/2013
    Labeler - Walgreen Co. (008965063)
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