STING RELIEF (ALCOHOL, LIDOCAINE HYDROCHLORIDE) CLOTH [ACME UNITED CORPORATION]

STING RELIEF (ALCOHOL, LIDOCAINE HYDROCHLORIDE) CLOTH [ACME UNITED CORPORATION]
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NDC 0924-5200-01, 0924-5200-02, 0924-5200-03
Set ID cee0edef-133f-404e-ba69-e14b602979c2
Category HUMAN OTC DRUG LABEL
Packager Acme United Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART333E
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient:

    Ethyl Alcohol 50.0%

    Lidocaine HCl 2.0%

  • Purpose:

    Antiseptic

    Analgesic (pain reliever)

  • Uses

    First aid analgesic to help prevent infection in and provide temporary relief of the pain of:

    • Insect bites and stings
    • Minor scrapes and burns
  • Warnings:

    For external use only. If swallowed, contact a doctor or poison control center immediately.

    Keep out of the reach of children. Flammable, keep away from open flame.

    DO NOT USE:

    • In the eyes
    • If you are allergic to any of the ingredients
    • On raw surfaces, blistered areas, or over large areas of the body

    WHEN USING THIS PRODUCT:

    • Avoid contact with eyes or mucous membranes

    STOP USE AND ASK A DOCTOR IF:

    • Conditions worsen clear up and then recur
    • The condition persists for more than 7 days
    • A rash, allergic reaction, swelling, irritation or infection occur
  • Directions:

    Packets are not child resistant. Tamper evident packaging, do not use if packet is opened or torn.

    Adults and children:
    over 2 years of age:

    Remove stinger carefully, if possible. Remove wipe from packet, clean affected area thoroughly no more than 3 times daily with saturated applicator.

    Children under 2:

    Consult your doctor.

  • Other information:

    Store at room temperature.

  • Inactive ingredients:

    Benzalkonium Chloride, Menthol, Purified Water

  • Questions about this product:

    Call 800-835-2263 with any questions about this product.

  • Principal Display Panel - Carton Label

    19-002

    MISC

    FIRST AID ONLY®

    Sting Relief Wipes

    10 Packets

    Toallitas para aliviar las molestias de picaduras

    10 sobres

    Principal Display Panel - Carton Label
  • Principal Display Panel - Carton Label

    G326

    MISC

    FIRST AID ONLY®

    Sting Relief Wipes

    50 Packets

    Toallitas para aliviar las molestias de picaduras

    50 sobres

    Principal Display Panel - Carton Label
  • Principal Display Panel - Packet Label

    Sting Relief

    Insect Bite Antiseptic
    and Pain Reliever

    1 Premoistened Towlette

    Package Not Child-Resistant

    FIRST AID ONLY®

    www.FirstAidOnly.com

    Fairfield, CT 06824

    1.800.835.2263

    © Acme United Corporation.

    810001-revA

    Principal Display Panel - Packet Label
  • INGREDIENTS AND APPEARANCE
    STING RELIEF 
    alcohol, lidocaine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol0.50 mL  in 1 mL
    lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    menthol (UNII: L7T10EIP3A)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5200-0210 in 1 BOX03/06/2012
    1NDC:0924-5200-010.9 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5200-0350 in 1 BOX03/06/2012
    2NDC:0924-5200-010.9 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/06/2012
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0924-5200)

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