Label: ALCOHOL PREP PAD WITH BENZOCAINE- benzocaine swab

  • 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 December 11, 2009

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  • ACTIVE INGREDIENTS

    Benzocaine 6%
    Isopropyl alcohol 70% v/v
  • PURPOSE

    Topical Anesthetic

    Antiseptic

  • USES

    • For preparation of the skin prior to injection
    • For temporary relief of pain and itching associated with minor burns, sunburn, minor skin irritations, or insect bites
  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use

    • in the eyes
    • with electrocautery procedures




    Stop use and ask a doctor

    • if irritation and redness develop
    • if symptoms persist for more than 72 hours or symptoms clear up and occur within a few days.


    Ask a doctor or pharmacist

    if you are pregnant or nursing a baby.

    Keep out of reach of children

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

  • DIRECTIONS

    Prior to Injection - Adults and children 2 years of age or older:
    Apply to the skin just prior to injection. Benzocaine takes a minute to act. for best results, wait briefly and then make injection.

    Insect bites, skin irritations, minor burns, sunburn -
    Adults and children 2 years of age or older:
    Apply to the affected site not more than 3 to 4 times daily.

    Children under 2 years of age: Ask a doctor.
  • SPL UNCLASSIFIED SECTION


  • STORAGE AND HANDLING

    • Store at room temperature: 15° - 30° C (59° - 86° F)
    • Do not use to clean and disinfect medical devices or hard surfaces.
  • INACTIVE INGREDIENTS

    propylene glycol, purified water
  • QUESTIONS


  • CARTON INFORMATION

    NDC 50730-1411-1

    Tamper Resistant. . . .do not use if product is torn or punctured


    CAREONE

    ALCOHOL
    Pain Relief SWABS

    70% ISOPROPYL ALCOHOL/BENZOCAINE

    • Convenient way to cleanse the skin
    • Antiseptic for preparation of the skin prior to injection


    80 Individually Foil Wrapped Wipes

    DIST. BY: American Sales Company
    4201 Walden Avenue, Lancaster, NY 14086
    ©2008 S and S BRANDS, INC.
    www.Care1.info

    Quality Guaranteed or your money back.

    CARTON


  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD WITH BENZOCAINE 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine.06 mL
    isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol.70 mL
    Inactive Ingredients
    Ingredient NameStrength
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-1411-180 in 1 CARTON
    11 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2008
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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