Label: MEGAFRESH HAND SANITIZER- alcohol liquid

  • 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 August 16, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    Antiseptic use for hand washing to decrease bacteria on the skin

  • WARNINGS

    Warnings:

    For external use only.

    Flammable. Keep away from fire or flame

    Do not use in the eyes. In case of contact, rinse eyes throughly with water

  • ASK DOCTOR

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center rigth away.

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands throughly with product. Briskly, rub hands together untill dry. Supervise children in the use of this product.

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water, Glycerin, Acrylic Acid, Trolamine, Fragrance

  • SPL UNCLASSIFIED SECTION

    Other Information

    May discolor certain fabrics

    Do not store above 105F

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEGAFRESH HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 36.70 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54157-105-0159 mL in 1 BOTTLE
    2NDC:54157-105-02118 mL in 1 BOTTLE
    3NDC:54157-105-03177 mL in 1 BOTTLE
    4NDC:54157-105-04237 mL in 1 BOTTLE
    5NDC:54157-105-05355 mL in 1 BOTTLE
    6NDC:54157-105-06473 mL in 1 BOTTLE
    7NDC:54157-105-0730 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/16/2014
    Labeler - American Amenities, Inc. (181454026)
    Registrant - American Amenities, Inc. (181454026)
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