DERMACEN INSTANT HAND SANITIZER- alcohol liquid

DermaCen Instant Hand Sanitizer by

Drug Labeling and Warnings

DermaCen Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Central Solutions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Ethanol 64.5% (w/w)

PURPOSE

Purpose

Hand Sanitizer

INDICATIONS & USAGE

Uses

An antiseptic hand sanitizer for topical application

Prevents infection and cross contamination

Reduces transient microorganisms on intact skin

Keep hands from drying due to repeated uses

WARNINGS

Warnings

For External Use Only

Flammable, keep away from fire or flame

When using this product

Avoid contact with eyes

In case of eye contact, flush with water for 15 minutes

Discontinue use and see a doctor if irritation occurs

Avoid contact with broken skin

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Wet hands thoroughly with product.

Allow to dry without wiping.

Use no water or towels.

USER SAFETY WARNINGS

Other Information

This product has not been tested on animals.

INACTIVE INGREDIENT

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, Water

PRINCIPAL DISPLAY PANEL

DermaCen

Instant

Hand Sanitizer

For hand washing to decrease bacteria on the skin.

Net Contents 8 ounces (236 ml)

INGREDIENTS AND APPEARANCE

DERMACEN INSTANT HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62654-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	64.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62654-140-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
2	NDC: 62654-140-03	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
3	NDC: 62654-140-36	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
4	NDC: 62654-140-90	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
5	NDC: 62654-140-92	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
6	NDC: 62654-140-91	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2018
7	NDC: 62654-140-93	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2001

Labeler - Central Solutions Inc (007118524)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions Inc		007118524	manufacture(62654-140)