MEGAFRESH HAND SANITIZER- alcohol liquid 
American Amenities, Inc.

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.

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Drug Fact

Active Ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Uses

Antiseptic use for hand washing to decrease bacteria on the skin

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

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

Keep out of reach of children.

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

Directions

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

Inactive Ingredient:

Water, Glycerin, Acrylic Acid, Trolamine, Fragrance

Other Information

May discolor certain fabrics

Do not store above 105F

image description

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)

Revised: 8/2014
Document Id: c3a3082d-477f-4bda-93a1-8421efdf6124
Set id: ec269d46-83ec-44e0-9ed6-d96b314048d8
Version: 1
Effective Time: 20140816
 
American Amenities, Inc.