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 Type HUMAN OTC DRUG Item Code (Source) NDC:62169-203
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 377.5 mL  in 500 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin (UNII: PDC6A3C0OX) 122.5 mL  in 500 mL
Product Characteristics
Color      Score     
Shape FREEFORM Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62169-203-12 12 in 1 PACKAGE
1 NDC:62169-203-17 500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/01/2014
Labeler - Laboratoires Anios (274758465)
Establishment
Name Address ID/FEI Business Operations
Laboratoires Anios 274758465 manufacture(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