Label: ISOPROPYL ALCOHOL WITH BENZOCAINE- isopropyl alcohol, 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 June 1, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts                  Figure

  • Active ingredient

    Isopropyl Alcohol, 70% v/v

    Benzocaine, 6%

  • Purpose

    Antiseptic

    Topical Anesthetic

  • Use

    For preparation of the skin prior to injection

    • For insect bites, skin irritations, minor burns and sunburn
  • Warnings

    For external use only

    • Flammable, keep away from fire or flame

    • Do not use: with electrocautery or in eyes

    • Stop use: if redness or irritation develops, if condition continues for more than 72 hours consult a physician.

    • Keep out of reach from children: If swallowed, get medical attention or call Poison Control immediately.
  • Directions

    Adults and children 2 years of age or older Apply as needed to clean intended area.

    For insect bites, skin irritations, minor burns and sunburn. Apply to affected site no more than 3 to 4 times daily. Discard after single use.

  • Inactive Ingredients

    30% purified water.

  • Other Information

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

    McKESSON

    Distribute By McKesson
    One Post Street, San Francisco, CA 94104
    Money Back Guarantee
    Please visit us at www.sunmarkbrand.com

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Box Label

    sunmark®

    NDC 49348-974-10

    sterile alcohol prep pads
    with benzocaine
    Antiseptic/Anesthetic

    Safe and easy to use

    70% Isopropyl Alcohol

    100 INDIVIDUALLY WRAPPED FOIL PACKETS

    1.18 X 1.18 IN (3 X 3 CM)

    Principal Display Panel – Box Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Packet Label

    sunmark®

    sterile alcohol prep pad
    with benzocaine
    Antiseptic/Anesthetic

    70% Isopropyl Alcohol
    6% Benzocaine

    Contains 1 Prep Pad

    Distributed By McKesson
    One Post Street, San Francisco, CA 94104

    Money Back Guarantee
    Please visit us at www.sunmarkbrands.com

    Made in China

    Principal Display Panel – Packet Label
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL WITH BENZOCAINE 
    isopropyl alcohol, benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-974
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.7 mL  in 1 mL
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.06 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-974-10100 in 1 BOX
    1.76 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2012
    Labeler - McKesson Corporation (177667227)
    Registrant - Shanghai Yinjing Medical Supplies Co., Ltd (530501535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Yinjing Medical Supplies Co., Ltd530501535MANUFACTURE(49348-974)
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