Label: MANILDRA STAY SAFE ALCOHOL ANTISEPTIC 80% HAND SANITIZER- ethanol liquid

  • Category: HUMAN OTC DRUG LABEL

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 24, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 80% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • hand sanitizer to help reduce bacteria that potentially can cause disease
    • for use when soap and water are not available
  • WARNINGS

    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 immediately.

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • SPL UNCLASSIFIED SECTION

    MANILDRA GROUP

    100% AUSTRALIAN OWNED

    Made in Australia

    Distributed by: Manildra Milling Corporation
    4501 College Blvd, Suite 310, Leawood, KS 66211

    manildra.com.au • 1-800-323-8435

  • PRINCIPAL DISPLAY PANEL

    stay safe™
    MANILDRA STAY SAFE™
    ALCOHOL ANTISEPTIC 80%
    TOPICAL SOLUTION HAND SANITIZER.
    Non-Sterile Solution
    FLAMMABLE LIQUID
    5L (1.3 Gal)

    Manildra Stay Safe Final

  • INGREDIENTS AND APPEARANCE
    MANILDRA STAY SAFE  ALCOHOL ANTISEPTIC 80% HAND SANITIZER
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79268-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79268-001-055 L in 1 JUG; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2020
    Labeler - Manildra Milling Coporation (188374060)
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

More Info on this Drug

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