Label: ALCOHOL PREP- isopropyl alcohol cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 25, 2020

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  • Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 70%

    Purpose

    Antiseptic

  • Use

    For preparation of the skin prior to injection.

  • Warnings

    • For external use only.
    • Flammable, keep away from fire or flame.

    Do Not Use

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

    Stop Use

    If irritation and redness develop. If condition continues, consult your health care practitioner.

    Keep out of reach of children.

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

  • Directions

    • Wipe desired area and discard.
  • Other information

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

  • Inactive Ingredients

    purified water

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73161-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73161-000-01200 in 1 BOX01/01/2019
    11 in 1 PACKAGE
    170 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34401/01/2019
    Labeler - Handy Care Ltd. DBA CBD Wipes (926174442)
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