MEGAFRESH HAND SANITIZER- alcohol liquid

MegaFresh Hand Sanitizer by

Drug Labeling and Warnings

MegaFresh Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by American Amenities, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MEGAFRESH HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54157-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	36.70 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ACRYLIC ACID (UNII: J94PBK7X8S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54157-105-01	59 mL in 1 BOTTLE
2	NDC: 54157-105-02	118 mL in 1 BOTTLE
3	NDC: 54157-105-03	177 mL in 1 BOTTLE
4	NDC: 54157-105-04	237 mL in 1 BOTTLE
5	NDC: 54157-105-05	355 mL in 1 BOTTLE
6	NDC: 54157-105-06	473 mL in 1 BOTTLE
7	NDC: 54157-105-07	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/16/2014

Labeler - American Amenities, Inc. (181454026)

Registrant - American Amenities, Inc. (181454026)