Label: FIRST AID ONLY ISOPROPYL ALCOHOL- isopropyl alcohol spray

  • 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 5, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Isopropyl Alcohol 70.0%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only.

    Flammable keep away from fire or flame.

    Do not use

    • in the eyes
    • over larger areas of the body
    • longer than 1 week unless directed by a doctor

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

    Stop use and ask a doctor

    • in case of deep puncture wounds, animal bites, or serious burns
    • if condition persists or gets worse
  • Directions

    • spray a small amount over cleaned affected area 1 to 3 times daily
    • if bandaged, let dry first
  • Inactive ingredient

    purified water

  • Principal Display Panel - Bottle Label

    FIRST AID ONLY®

    M5123

    ANTISEPTICS

    Isopropyl Alcohol

    Helps prevent infection for
    use on cuts and burns

    4 fl oz (118.3ml)

    NDC 0924-0170-04

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY ISOPROPYL ALCOHOL  
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol 700 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0170-040.1183 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/26/2014
    Labeler - Acme United Corp. (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0924-0170)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!