Label: ALCOHOL ANTISEPTIC- alcohol solution

  • 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 July 26, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v.............................. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    aloe vera gel, amino methyl propanol, carbomer, FD&C blue #1·, FD&C yellow #10·, fragrance, purified water, vitamin E
    •may contain one or more of these ingredients if the product is a colored gel.

  • Package Label - Principal Display Panel

    8 fl oz (237 mL) NDC: 73414-057-08

    containerlabel8floz

    16 fl oz (473 mL) NDC: 73414-057-13

    containerlabel16floz

    32 fl oz (946 mL) NDC: 73414-057-14

    containerlabe32floz

    1 Gallon (3.78 L) NDC: 73414-057-91

    containerlabel1gal

  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73414-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73414-057-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:73414-057-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    3NDC:73414-057-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    4NDC:73414-057-08177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    5NDC:73414-057-13473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    6NDC:73414-057-14946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    7NDC:73414-057-913780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Seaway Pharma Inc. (117218785)
    Registrant - Seaway Pharma Inc. (117218785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seaway Pharma Inc.117218785manufacture(73414-057)
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