Label: ALCOHOL- 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 December 18, 2012

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  • Active ingredient

    Isopropyl alcohol, 70% v/v

  • Purpose

    Antiseptic

  • Uses

     
    For preparation of the skin prior to injection
  • Warnings

    For external use only.

    When using this product

    • Do not get into eyes
    • apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

    Stop use and ask a doctor if

    • condition persists or gets worse or lasts for more than 72 hours
    • do not use longer than 1 week unless directed by a doctor

    Flammable

    • Keep away from fire or flame
    • Do not use with electrocautery procedures
    • Use only in a well-ventilated area, fumes may be toxic

    Keep out of reach of children.

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

  • Directions

    Wipe injection site vigorously. Discard after single use.

  • Other information

    Protect from freezing and avoid excessive heat.

  • Inactive ingredients

    Water

  • Package/Label Principal Display Panel

    Fred's Alcohol Swabs box -  Front, Side, Bottom

    FRED'S

    Alcohol Swabs

    Antiseptic for preparation of the skin prior to injection

    Thicker, Softer

    • Individually Foil Wrapped
    • 70% Isopropyl Alcohol

    100 SWABS

  • Package/Label Back

    Fred's Alcohol Swabs box -  Top, Side, Bottom, Back

    Fred's Alcohol Swabs Box Top, Back, Side, Bottom

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-809
    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:55315-809-30100 in 1 BOX
    11 in 1 PACKET
    15 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2011
    Labeler - Fred's Inc. (005866116)