Label: ADVENTURE FIRST AID WATER RESISTANT- benzocaine, alcohol kit

  • 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 15, 2017

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  • Active Ingredient - Antiseptic

    Benzalkonium Chloride 0.13%

  • Purpose - Antiseptic

    Antiseptic

  • Use - Antiseptic

    For Professional and hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

  • Warnings, Precautions and Directions - Antiseptic

    For External use only.

    Keep out of Reach of Children.

    Stop use if unusual redness, swelling or other symptoms occur, consult a physician immediately.

    Do not uses in eyes or over large areas of the body.

    Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

  • Inactive Ingredients - Antiseptic

    Purified Water

  • Active Ingredient - Alcohol Prep Pad

    Isopropyl Alcohol 70%

  • Use - Alcohol Prep Pad

    For preparation of the skin before injection

  • Warnings, Precautions and Directions - Alcohol Prep Pad

    For External Use Only

    Flammable - Keep away from fire or flame

    Do Not Use - with electrocautery, in eyes

    Stop Use and Ask a Doctor if - Irritation or redness develop and persists for more than 72 hours

    Keep out of Reach of Children

    If swallowed, get medical help or contact a poison control center right away.

    Tear Open packet, unfold and use as and wipe injection site vigorously and discard.

    Store at Room Temperature

  • Active Ingredients - Insect Relief Pad

    Benzocaine 6%

    SD alcohol 60%

  • Purpose - Insect Relief Pad

    Topical Anesthetic - Antiseptic

  • Use - Insect Relief Pad

    For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites

  • Warnings, Precautions and Directions - Insect Relief Pad

    Clean intended area thoroughly with pad. Discard after single use

    Warnings: For external use only.

    Avoid contact with eyes. If this happens, rinse thoroughly with water

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

    Flammable - keep away from fire or flame

    Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

  • Adventure First Aid Water Resistant

    HangtagHangtagAlcohol PadISRPAntiseptic Wipe

  • INGREDIENTS AND APPEARANCE
    ADVENTURE FIRST AID WATER RESISTANT 
    benzocaine, alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-0120
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-0120-11 in 1 BOX; Type 0: Not a Combination Product10/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKAGE 3 mL  in .8 
    Part 22 PACKAGE 1 mL  in .5 
    Part 34 PACKAGE 3 mL  in .7 
    Part 1 of 3
    ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:52124-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-10.8 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2010
    Part 2 of 3
    INSECT STING RELIEF PAD 
    benzocaine,alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.6 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0008-10.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/23/2011
    Part 3 of 3
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0017-10.7 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2015
    Labeler - Tender Corporation (064437304)
    Registrant - Tender Corporation (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(44224-0120)