Label: ALCOHOL PREP PADS WITH PAIN RELIEF- 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 September 19, 2010

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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


  • OTHER INFORMATION

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

    propylene glycol, water
  • QUESTIONS


  • CARTON INFORMATION

    sunmark®

    NDC 49348-897-39

    alcohol prep pads

    Antiseptic / Anesthetic
    Safe and easy to use
    Isopropyl Alcohol 70%

    WITH BENZOCAINE FOR PAIN RELIEF

    80 INDIVIDUALLY WRAPPED FOIL PACKETS


    Another Quality Product Distributed by McKesson
    One Post Street, San Francisco, CA 94104
    Money Back Guarantee

    Visit us at www.sunmarkbrand.com

    CARTON

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PADS WITH PAIN RELIEF 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-897
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine0.06 mL
    isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol0.70 mL
    Inactive Ingredients
    Ingredient NameStrength
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-897-3980 in 1 CARTON
    11 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/19/2010
    Labeler - McKesson (177667227)
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