Label: BEKOOOL ITCH RELIEF  - lidocaine and menthol patch 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active ingredients

    Lidocaine 2 percent

    Menthol 1 percent

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  • Purpose

    External analgesic

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  • Uses

    Temporary relief of pain and itching associated with:

    • insect bites
    • Minor skin irritations and rashes due to poison ivy
    • Minor cuts and scrapes

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  • Warnings

    For external use only

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  • Do not use

    • Do not use on chicken pox, measles, blisters, eczema, mucous membranes, near the eyes or an extensive ares of the skin
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  • When using this product

    • Wash hands after applying or removing patch.
    • For adults and children two years or older, apply to affected area of skin only
    • On children under 2 years or anyone with allergies, consult a doctor
    • Do not get in eyes
    • Do not swallow or injest
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  • Stop use and ask a doctor if

    • Condition persists or worsens.
    • Rash, redness, swelling occurs or pain increases
    • Symptoms persist for more than 7 days, or clear up and occur again within a few days
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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults and children 2 years of age and older:

    • Do not use more than directed
    • Clean and dry affected area
    • Cut or tear open pouch and remove one sheet
    • Remove patch from sheet
    • Apply patch directly to affected area
    • Store unused patch in the pouch. Reseal pouch by tightly folding the pouch twice along the dotted lines.
    • Apply patch one to three times a day to affected area
    • Apply patch for up to 5 hours
    • Avoid applying patches to same location for an extended period, especially to sensitive skin
    • If itching persists re-apply a new patch as needed
    • Children under 2 years of age: consult a doctor
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  • Other information

    Store in a cool place 68-77 degrees F (20-25 degrees C) avoiding direct sunlight, high temperature and humidity. Store unused patches in the pouch. Do not store in other containers. Reseal the pouch to prevent remaining patches from drying out by tightly folding the pouch twice.

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  • Inactive ingredients

    Alicyclic Saturated Hydrocarbon Resin, Butylated Hydroxytoluene, Hydrogenated Rosin Glycerol Ester, Mineral Oil, Polyisobutylene, Styrene-Isoprene-Styrene Block Copolymer

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  • Package label

    BeKoool

    New

    STOP THE ITCH QUICK!
    ITCH
    RELIEF
    PATCHES
    FAST-ACTING MEDICATED

    Temporarily relieves pain and itching associated with:

    • insect bites
    • poison ivy
    • minor skin irritations
    Nearly Invisible on Skin
    Prevents Scratching
    Protects the Irritated Area
    18 Patches
    1.1" x 1.1" (2.8cm x 2.8cm) each.
    For external use only.

    Distributed by:
    KOBAYASHI
    Healthcare, LLC
    P.O. Box 2527
    Dalton, GA 30722

    • Works fast
    • Stays in place
    • Prevents scratching
    • Non-messy
    Itch Relief Patches takes the itch away!
    • Clear nearly invisible on skin
    • Protective Patch prevents scratching and helps protect irritated area
    • Non-messy no creams or gels to touch
    • Easy to use just peel and apply
    For maximum benefit, please read package directions and instructions carefully before using.

    BeKoool TM medicated Itch Relief Patches give fast-acting targeted relief from itching due to insect bites, minor skin irritations, cuts and scrapes.

    Convenient, disposable and easy to use, they are thin enough to use under clothing. Patches are great for the whole family and provide a physical barrier to prevent scratching, which can lead to further infection. Perfect for active kids and adults!

    Lot No. :
    Exp. Date :

    Item # 00900

    MADE IN KOREA
    1012.0 00

    Consumer Comments
    Call: 706-266-1815

    www.kobayashihealthcare.com

    package label



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  • INGREDIENTS AND APPEARANCE
    BEKOOOL ITCH RELIEF  
    lidocaine, menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54273-000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 20 mg  in 1 mL
    MENTHOL (MENTHOL) MENTHOL 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    MINERAL OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54273-000-18 18 in 1 BOX
    1 0.07 mL in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/30/2012
    Labeler - Heatmax Inc. (618672760)
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