Label: MEDLINE ALCOHOL PREP STERILE, LARGE- isopropyl alcohol swab

  • NDC Code(s): 53329-811-09, 53329-811-30
  • Packager: Medline Industries, LP
  • 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 August 24, 2023

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  • Active ingredient

    Isopropyl alcohol 70% v/v

  • Purpose

    First aid antiseptic

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burns
  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product

    • do not get in the eyes or apply over large areas of the body
    • in case of deep or puncture wounds, animal bites or serious burns, consult a doctor
    • do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • condition persists or gets worse

    Keep out of reach of children.

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

  • Directions

    • clean the affected area
    • discard after a single use
    • may be covered with a sterile bandage
  • Other information

    • protect from freezing, avoid excessive heat
    • do not flush
    • not made with natural rubber latex
  • Inactive ingredient

    water

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Packaged in China with Components from Taiwan

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MDS090670

    V3 RG23SXM

  • Package Label

    Packet V3 RG23SXM

    Box V3 RG23SXM

  • INGREDIENTS AND APPEARANCE
    MEDLINE ALCOHOL PREP  STERILE, LARGE
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-811
    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:53329-811-30100 in 1 BOX01/01/2007
    11 in 1 PACKET
    15 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53329-811-091 in 1 PACKET01/01/2007
    25 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2007
    Labeler - Medline Industries, LP (025460908)
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