Label: AFTER BITE WIPE- ethyl alcohol, lidocaine hcl liquid

  • 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 November 4, 2016

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  • Active Ingredients

    Ethyl Alcohol 50.0%

    Lidocaine HCl 2.0%

  • Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    First aid to help prevent infrection in minor scrapes and temporary relief of itching and insect bites

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame

  • Do Not Use

    • over large areas of the body
    • in eyes
    • over raw or blistered areas
  • Stop use and ask a doctor

    if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children

    If swallowed get medical kep or contact Poison Control Center right away

  • Directions

    Adults and Children 2 years and older: Apply to cleaned affected area not more than 3 times daily.

    Children under 2 years of age: consult a doctor.

  • Inactive Ingredients

    benzalkonium chloride, menthol, purified water

  • After Bite

    After Bite

    Afterbite.com

    Fast Relief from Insect Bites.

    Contents: 1 single-use, premoistened towelette

    Net contents: 0.037fl.oz.

    Manufactured for: Tender Corporation Littleton, NH 03561 USA

    After Bite Wipe

  • INGREDIENTS AND APPEARANCE
    AFTER BITE WIPE 
    ethyl alcohol, lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-3621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-3621-01.1 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2016
    Labeler - Tender Corporation (064437304)
    Registrant - Tender Corporation (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(44224-3621)
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