Azuro by Noveko Inc AZURO- alcohol gel

Azuro by

Drug Labeling and Warnings

Azuro by is a Otc medication manufactured, distributed, or labeled by Noveko Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

70% V/V Ethyl alcohol.....Antiseptic

INDICATIONS & USAGE

Uses

for handwashing to decrease bacteria on the skin

recommended for repeated use

WARNINGS

Warnings

For external use only.

Flammable, keep away from fire or flame.

DO NOT USE

Do not use in the eyes.  In case of

contact, rinse eyes thoroughly

with water.

STOP USE

Discontinue use if irritation and

redness develop.

ASK DOCTOR

If condition persists

for more than 72 hours, consult

a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If

swallowed, get medical help or contact

a Poison Control Center right away.

INDICATIONS & USAGE

Directions

wet hands thoroughly with product

and allow to dry without wiping

supervise children in the use of this product

GENERAL PRECAUTIONS

Other Information

avoid temperature over 110F

may discolor certain fabrics

harmful to wood finishes and plastics

INACTIVE INGREDIENT

Inactive ingredients

Water, Aloe vera, Carbomer, Tocopheryl acetate, Triethanolamine,

Glycerin, Fragrance.

QUESTIONS

Questions?

call 1 866 377-3030

weekdays, 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

Enter section text here

PRINCIPAL DISPLAY PANEL

ANTISEPTIC HAND SANITIZER

AZURO

ORIGINAL

SCENTED GEL

KILLS 99.9% OF COMMON BACTERIA OR GERMS!

70% V/V Ethyl Alcohol

formula enriched with

Vitamin E and Aloe vera.

Simple and convenient,

Azuro sanitizes without

the use of water.

Emollients leave hands

feeling soft and smooth

even during prolonged use.

   fl oz. (  L/mL)

INGREDIENTS AND APPEARANCE

AZURO  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49955-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49955-100-10	1 L in 1 BOTTLE
2	NDC: 49955-100-13	1.3 L in 1 BOTTLE
3	NDC: 49955-100-50	0.5 L in 1 BOTTLE
4	NDC: 49955-100-25	0.25 L in 1 BOTTLE
5	NDC: 49955-100-60	0.06 L in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/18/2009

Labeler - Noveko Inc (205614519)