Label: DENA-VIE FIRST AID ANTISEPTIC- 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 October 2, 2023

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol USP (70 % conc.)

  • Purpose

    First aid antiseptic

  • Uses

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

  • Warnings

    For external use only. If taken internally, serious gastric disturbances will result. Flammable, keep away from fire or flame. Use only in a well-ventilated area; fumes may be toxic.

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

    When using this product:

    Do not get into eyes ; • Do not spray over large areas of the body; • Do not use longer than one week unless directed by a doctor.

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions:

    clean affected area; • spray small amount of this product on the area 1-3 times daily; • if bandaged, let dry first; • may be covered with a sterile bandage.

  • Other information:

    Store at room temperature; • does not contain, nor is intended as a substitute for grain or ethyl alcohol.

  • Inactive ingredient:

    Deionized Water

  • SPL UNCLASSIFIED SECTION

    For Rubbing & Massaging

    WARNING FLAMMABLE

    Keep away from heat, spark, electrical, fire or flame.

    USE ONLY IN A WELL-VENTILATED AREA, FUMES MAY BE HARMFUL CAUTION: DO NOT POINT AT SELF OR OTHERS; PRODUCT WILL SQUIRT WHEN SQUEEZED

    Dena Vie

    Division of Dena Brands USA Ltd

    P.O. Box 66445, Chicago, Illinois 60666 USA

    www.denabrandsusa.com

    Made in the USA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    DENA-VIE FIRST AID ANTISEPTIC 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80937-222
    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:80937-222-2259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/10/2020
    Labeler - Dena Brands Usa Ltd. (809856482)
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