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ANIOSGEL 85 NPC

Dosage form: gel
Ingredients: ALCOHOL 377.5mL in 500mL
Labeler: Laboratoires Anios
NDC Code: 62169-203

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.

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

BACK LABEL

ANIOSGEL 85  NPC
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:62169-203-1212 BOTTLE, PLASTIC 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/FEIOperations
Laboratoires Anios274758465manufacture(62169-203)

Revised: 05/2014
 
Laboratoires Anios

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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