DERMAPHEX HAND SANITIZER solution

DermAphex Hand Sanitizer by

Drug Labeling and Warnings

DermAphex Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aphex Biocleanse Systems, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

Directions: Refill your container. 1 - 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands. Continue rubbing until dry.

Use frequently to avoid spreading germs.

Warnings

Warnings:

For External Use Only
Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
Discontinue use if skin irritation or redness develops. Not for use on sensitive areas of the body or burns.
If swallowed, get medical help or contact a poison control center right away.
Keep Out of Reach of Children

Inactive Ingredient

Inactive ingredients: -Water 99.83% -Carbamide to 0.04%

Indications and Usage

Uses: For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Keep out of Reach of Children

Warnings:

For External Use Only
Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
Discontinue use if skin irritation or redness develops. Not for use on sensitive areas of the body or burns.
If swallowed, get medical help or contact a poison control center right away.
Keep Out of Reach of Children

Purpose

Active ingredients: Benzalkonium Chloride 0.11% - 0 .13%

(As sanitizing agent)

Active Ingredient

Active ingredients: Benzalkonium Chloride 0.11% - 0 .13%

(As sanitizing agent)

DermAphex 275 Gallon Container

DermAphex 55 Gallon

INGREDIENTS AND APPEARANCE

DERMAPHEX HAND SANITIZER 
dermaphex hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78003-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
UREA (UNII: 8W8T17847W)	0.0006 g  in 1 mL
WATER (UNII: 059QF0KO0R)	1 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78003-120-80	1054000 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2012
2	NDC: 78003-120-70	208000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2012

Labeler - Aphex Biocleanse Systems, Inc (012445467)

Registrant - Aphex Biocleanse Systems, Inc (012445467)

Establishment
Name	Address	ID/FEI	Business Operations
Aphex Biocleanse Systems, Inc		117531318	manufacture(78003-120)