Label: CUT CARE ALCOHOL PREP PAD- 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 September 9, 2013

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  • SPL UNCLASSIFIED SECTION

  • Active ingredient

    Isopropyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    For preparation of the skin prior to injection

  • Warnings

    • For external use only
    • Flammable, keep away from flame or fire
    • Not for use with electrocautinary devices or procedures
    • Do not use in eyes
    • Sterile unless package is damaged or open.

    Stop use and ask a doctor if:

    • Irritation or redness develops
    • condition persists for more than 72 hours

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions

    • Wipe injection site vigorously and discard
  • Other information

    store at room temperature: 15○ - 30○C (59○F – 86○F)

    • avoid excessive heart
  • Inactive Ingredient

    purified water

  • PRINCIPAL DISPLAY PANEL

    NDC 53439-100-10
    Cut Care
    Alcohol Prep Pad
    Saturated with 70% Isopropyl Alcohol
    Contents: 100 Pouches

    PRINCIPAL DISPLAY PANEL NDC 53439-100-10 Cut Care Alcohol Prep Pad Saturated with 70% Isopropyl Alcohol Contents: 100 Pouches

  • INGREDIENTS AND APPEARANCE
    CUT CARE ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53439-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53439-100-10100 in 1 CARTON
    1NDC:53439-100-011 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A09/15/2013
    Labeler - Zeus Medical Holdings LLC (014884052)
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