Label: ALCOHOL ANTISEPTIC- alcohol solution

  • NDC Code(s): 67234-075-01, 67234-075-02
  • Packager: Natureplex LLC
  • 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 April 3, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient[s]

    Alcohol 80% 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

    glycerin, hydrogen peroxide, purified water USP

  • PRINCIPAL DISPLAY PANEL - 3785.41 mL Jug Label

    Natureplex Alcohol Antiseptic 80%
    Topical Solution
    NDC 67234-075-01

    Hand Sanitizer
    Non-sterile Solution

    Natureplex, LLC
    11085 Airport Rd Olive Branch, MS 38654
    1-866-323-0107

    Lot: XXXX
    Part No: 3147

    NATUREPLEX

    1 gallon (3785.41 mL)

    PRINCIPAL DISPLAY PANEL - 3785.41 mL Jug Label
  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC  
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-075-013785.41 mL in 1 JUG; Type 0: Not a Combination Product03/27/2020
    2NDC:67234-075-02208198 mL in 1 DRUM; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E03/27/2020
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-075)
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