Label: ALCOHOL PREP PADS- 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 November 5, 2022

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  • Active Ingredient

    Isopropyl Alcohol USP, 70% v/v

  • Purpose

    Antiseptic

  • Use:

    For preparation of the skin prior to injection; to decrease germs in minor cuts and scrapes.

  • WARNINGS:

    • For external use only. Flammable; keep away from fire and flame.

    Keep out of reach of children.

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

    Caution:

    Do not apply to irritated skin.

    Do not use

    in the eyes, or on mucous membranes. In case of deep or puncture wounds, consult a doctor.

  • Directions:

    Wipe vigorously to clean the area.

  • Other information:

    Store at room temperature.

  • Inactive ingredient:

    Water

  • Principal Display Panel

    HENRY SCHEIN  112-6131

    ALCOHOL PREP PADS

    NDC 0404-0007-02

    200 Packets/Sobres

    Sachets/Packung/Confezioni

    STERILE

    Sterilized using irridiation

    Do not reuse

    Do not use if package is opened or damaged

    Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PADS 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0007
    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:0404-0007-02200 in 1 CARTON10/27/2015
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/27/2015
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Phoenix Innovative Healthcare Manufacturers Private Limited (650743854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phoenix Innovative Healthcare Manufacturers Private Limited650743854manufacture(0404-0007)
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