Label: ALCOHOL- 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 August 29, 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

    • the 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

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

    water

  • Manufacturing Information

    Distributed by:

    Foodhold U.S.A. LLC

    8301 Professional Pl, Greater Landover, MD 20785 USA

    Made in China

    1-877-846-9949

    REF: AHD090731SC

    V1 RH23LPD

  • Package Label

    Packet V1 RH23LPD

    Box V1 RH23LPD

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-809
    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:41520-809-30100 in 1 BOX04/08/2011
    11 in 1 PACKET
    10.5 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 finalpart333A04/08/2011
    Labeler - Foodhold U.S.A. LLC (809183973)
    Registrant - Medline Industries, LP (025460908)
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