Label: SHOPKO ALCOHOL SWABS- isopropyl alcohol 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 April 10, 2014

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  • Active ingredient

    Isopropyl alcohol, 70% v/v

  • Purpose

    Antiseptic

  • Uses

    •
    for preparation of the skin prior to injection
    •
    First aid to decrease germs in minor cuts, scrapes and burns
  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use

    •
    with electrocautery procedures
    •
    Longer than 1 week unless directed by doctor

    When Using This Product

    •
    Do not get into eyes
    •
    Do not apply over large areas of the body
    •
    In case of deep or puncture wounds, animal bites or serious burns, consult a doctor

    Stop use and ask a doctor if

    •
    irritation and redness develop
    •
    condition 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.

  • Directions

    •
    Apply to skin as needed
    •
    Discard after single use
  • Other information

    Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    Water

  • Package/Label Principal Display Panel 100 count

    Shopko pharmacy Sterile Alcohol Prep Swabs 100 count box

    Shopko

    37012-499-30

    Alcohol Swabs

    Isopropyl Alcohol 70%

    Antiseptic Skin Cleanser

    Sterile Antiseptic for preparation of the skin prior to injection

    Thick and soft

    100 Individually Wrapped Foil Packets

  • Principal Display Panel

    C:\Documents and Settings\gateway1\My Documents\37012-499 - ShopKo Alcohol Prep Pad Back and Side Panel
  • INGREDIENTS AND APPEARANCE
    SHOPKO ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-499
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-499-30100 in 1 BOX
    11 in 1 PACKET
    15 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2014
    Labeler - SHOPKO STORES OPERATING CO., LLC (023252638)
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