ANIOSGEL 85 NPC- alcohol gel 
Laboratoires Anios

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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Indications & Usage:

HYDROALCOHOLIC ANTISEPTIC GEL FOR SKIN AND HANDS

Active Ingredients Purpose
Ethanol 70.0% (w/w) ....................................Antisepsis

Instructions for Use/Directions

Hygienic Treatment: Apply 3 ml of gel to cupped palm of hands. Rub fingertips and hands thoroughly until completely dry, for at least 30 seconds.

Surgical disinfection: 2 x 3 ml for a hand rubbing time of 2 x 45 seconds.

• Do not rinse

For Dosage and Administration, please refer to "INSTRUCTIONS FOR USE SECTION"

Warnings and Precautions
For external use only
• Do not swallow
• Keep away from heat source
• If accidental eye contact occurs, rinse thoroughly with water
• If irritation persists, consult a physician

ln case of ingestion, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

OTC Purpose/Use

• Hygienic treatment
• Surgical disinfection

Inactive Ingredients:

Inert ingredients 30.0% (w/w)

For Warnings, please refer to "WARNINGS AND PRECAUTIONS SECTION"

FRONT LABEL
Front Label

BACK LABEL

Back Label

ANIOSGEL 85  NPC
ethanol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62169-203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL377.5 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin122.5 mL  in 500 mL
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62169-203-1212 in 1 PACKAGE
1NDC:62169-203-17500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2014
Labeler - Laboratoires Anios (274758465)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Anios274758465manufacture(62169-203)

Revised: 5/2014
Document Id: b39b4a9b-56e8-43f2-89d5-319b6cf2e337
Set id: 5ee820cd-2dca-40d5-bd96-bbd54131c2f0
Version: 3
Effective Time: 20140509
 
Laboratoires Anios