Label: LABOFLEX COOL AND HOT MENTHOL 1.25 PERCENT CAPSAICIN 0.025 PERCENT- menthol, capsaicin patch

  • NDC Code(s): 82957-103-11, 82957-103-12
  • Packager: WOOSHIN LABOTTACH CO., LTD.
  • 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 March 14, 2023

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  • ACTIVE INGREDIENTS

    Menthol 1.25%

    Capsicum extract 0.025% as Capsaicin

  • INACTIVE INGREDIENTS

    Aluminum Glycinate, Butylhydroxytoluene(BHT), Carboxymethylcellulose Sodium, Glycerin, Disodium EDTA, Kaolin, Polysorbate 80, Povidone-K90, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water

  • PURPOSE

    Topical Analgesic

  • WARNINGS

    For external use only

    Do not use ■ On wounds or damaged skin ■ With a heating pad ■ If you are allergic to any ingredients of this product.

  • 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

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains

  • Directions

    Adult and children 12 years of age and over :

    ■ Clean and dry affected area ■ Remove film from patch and apply to the skin ■ Apply to affected area not more than 3 to 4 times daily ■ Remove patch from the skin after at most 8-hour application.

    Children under 12 years of age : Consult a doctor

  • Other Information

    ■ Avoid storing product in direct sunlight ■ Protect product from excessive moisture

  • Questions or Comments

    Questions or comments? Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

  • When using this product

    When using this product ■ Use only as directed ■ Avoid contact with the eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Discontinue use at least 1 hour before a bath or shower ■ Do not use immediately after a bath or shower.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if ■ Skin reactions such as redness, itching, rash excessive irritation, burning sensation, swelling or blistering occur ■ Condition worsen ■ Symptoms persist for more than 7 days ■

    Symptoms clear up and occur again within a few days.

  • If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    CartonLabel

  • INGREDIENTS AND APPEARANCE
    LABOFLEX COOL AND HOT MENTHOL 1.25 PERCENT CAPSAICIN 0.025 PERCENT 
    menthol, capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82957-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL87.5 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82957-103-112 in 1 CARTON02/20/2023
    15 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:82957-103-125 in 1 POUCH; Type 0: Not a Combination Product02/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/20/2023
    Labeler - WOOSHIN LABOTTACH CO., LTD. (688269808)
    Registrant - WOOSHIN LABOTTACH CO., LTD. (688269808)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOOSHIN LAPACHE d.o.o.507385209manufacture(82957-103)
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