Label: ALCO-GEL- alcohol gel

  • NDC Code(s): 54555-131-01, 54555-131-02, 54555-131-03, 54555-131-04
  • Packager: Brainerd Chemical Company Inc.,
  • 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 June 30, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient[s]

    Isopropyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • Use(s)

    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

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

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

    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. 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

    hydrogen peroxide, purified water USP, d-limonene, cocamidopropyl betaine, hydroxypropyl methylcellulose

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Nyco Products Company
    5332 Dansher Rd. • Countryside, IL 60525

  • PRINCIPAL DISPLAY PANEL - 3.785 L Jug Label

    Nyco®
    Hand Care

    Alco-Gel Plus

    Hand Sanitizer

    • Kills 99.99% of common germs that can cause illness
    • Evaporates Quickly • Leaves hands smooth and refreshed

    KEEP OUT OF THE REACH OF CHILDREN.
    FOR INSTITUTIONAL AND INDUSTRIAL USE

    NET CONTENTS: 1 GAL / 3.785 L

    PRINCIPAL DISPLAY PANEL - 3.785 L Jug Label
  • INGREDIENTS AND APPEARANCE
    ALCO-GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54555-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) alcohol750 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    hydrogen peroxide (UNII: BBX060AN9V)  
    water (UNII: 059QF0KO0R)  
    LIMONENE OXIDE, TRANS-(+)- (UNII: 8VUQ1B30IK)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54555-131-041040.9 L in 1 TANK; Type 0: Not a Combination Product07/01/2020
    2NDC:54555-131-03208.1 L in 1 DRUM; Type 0: Not a Combination Product07/01/2020
    3NDC:54555-131-0218.9 L in 1 JUG; Type 0: Not a Combination Product07/01/2020
    4NDC:54555-131-013.785 L in 1 JUG; 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 - Brainerd Chemical Company Inc., (787442417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brainerd Chemical Company Inc.,787442417MANUFACTURE(54555-131) , LABEL(54555-131) , PACK(54555-131) , REPACK(54555-131)