Label: ALPHAPROMED ALPHACOL STERILE ISOPROPYL ALCOHOL PREPARATION PAD- 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 February 15, 2021

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol 70%......................Antiseptic

  • PURPOSE

    Antiseptic

  • Use

    For preparation of the skin prior to an injection

  • Warnings

    • For external use only.
    • Flammable, keep away from fire or flame.
  • Do not use

    • with electrocautery procedures.
    • in the eyes. If contact occurs, flush eyes with water.
  • Stop use

    if irritation and redness develop.If condition persists consult your health care parctitioner.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Wipe topically and discard after use.

  • Other information

    Store at room temperature 15-30C (59-86F)

  • INACTIVE INGREDIENT

    Water

  • PRINCIPAL DISPLAY PANEL

    Label1Label2

  • INGREDIENTS AND APPEARANCE
    ALPHAPROMED ALPHACOL STERILE ISOPROPYL ALCOHOL PREPARATION PAD 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81444-002
    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:81444-002-011 in 1 PACKAGE06/23/2020
    12.7 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 finalpart333A06/23/2020
    Labeler - Bay Promo, LLC (080790703)
    Establishment
    NameAddressID/FEIBusiness Operations
    QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.529667276manufacture(81444-002)
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