AZURO  - alcohol gel 
Noveko 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.

----------

Active ingredient Purpose

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

Uses

for handwashing to decrease bacteria on the skin

recommended for repeated use

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use in the eyes.  In case of

contact, rinse eyes thoroughly

with water.

Discontinue use if irritation and

redness develop.

If condition persists

for more than 72 hours, consult

a doctor.

Keep out of reach of children.  If

swallowed, get medical help or contact

a Poison Control Center right away.

Directions

wet hands thoroughly with product

and allow to dry without wiping

supervise children in the use of this product

Other Information

avoid temperature over 110F

may discolor certain fabrics

harmful to wood finishes and plastics

Inactive ingredients

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

Glycerin, Fragrance.

Questions?

call 1 866 377-3030

weekdays, 9AM - 5PM EST

Enter section text here

1L Bottle Label

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)

AZURO  
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49955-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49955-100-101 L in 1 BOTTLE
2NDC:49955-100-131.3 L in 1 BOTTLE
3NDC:49955-100-500.5 L in 1 BOTTLE
4NDC:49955-100-250.25 L in 1 BOTTLE
5NDC:49955-100-600.06 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33311/18/2009
Labeler - Noveko Inc (205614519)

Revised: 1/2010
Document Id: 1f8fe83c-fcaf-489e-b0b8-01817ee2a81a
Set id: d920cf43-356d-43e6-af53-6b5f754fc8e4
Version: 3
Effective Time: 20100104
 
Noveko Inc