Label: ALCOHOL PREP PAD MEDIUM PAD- isopropyl alcohol cloth

  • 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 March 26, 2021

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  • Drug Facts:

  • 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 Ingredients:

    Purified Water

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD MEDIUM PAD 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-9407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-9407-02200 in 1 BOX01/01/2021
    10.68 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2021
    Labeler - Henry Schein Inc. (012430880)
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