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Name:Azuro
Manufacturer:Noveko Inc
Category:Over-the-counter (OTC) Marketed Drugs


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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:49955-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 L  in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER  
ALOE VERA LEAF  
.ALPHA.-TOCOPHEROL ACETATE, D-  
TROLAMINE  
GLYCERIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49955-100-10 1 L in 1 BOTTLE None
2 NDC:49955-100-13 1.3 L in 1 BOTTLE None
3 NDC:49955-100-50 0.5 L in 1 BOTTLE None
4 NDC:49955-100-25 0.25 L in 1 BOTTLE None
5 NDC:49955-100-60 0.06 L in 1 BOTTLE None

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)

Revised: 01/2010 Noveko Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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