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 4, 2022

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol USP 70% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    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.

  • OTHER SAFETY INFORMATION

    Do not apply to irritated skin.

  • DO NOT USE

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

  • DOSAGE & ADMINISTRATION

    Wipe vigorously to clean the area.

  • STORAGE AND HANDLING

    Store at room temperature.

  • INACTIVE INGREDIENT

    Water

  • PRINCIPAL DISPLAY PANEL

    Inner Box

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PADS 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0103
    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:0404-0103-02200 in 1 BOX01/01/2021
    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 finalpart333A01/01/2021
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Phoenix Innovative Healthcare Manufacturers Private Limited (650743854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phoenix Innovative Healthcare Manufacturers Private Limited650743854manufacture(0404-0103)