ANIOSGEL 85 NPC- ethanol gel

ANIOSGEL 85 by

Drug Labeling and Warnings

ANIOSGEL 85 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Anios. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 70.0% (w/w)

Purpose

Antisepsis

INDICATIONS & USAGE

Uses

Hygienic treatment
Surgical disinfection

WARNINGS

Warnings
For external use only

Flammable
Keep away from sparks and open flames.
Highly flammable liquid and vapor.

WHEN USING

When using this product
Use in well-ventilated areas.
Avoid all contact with eyes. Causes serious eye irritation.
IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing. If
necessary, call a Poison Control Center or a physician.
Do not smoke when using the product.

STOP USE

Stop use and ask a doctor if skin irritation develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions
Ready to use gel.
Hygienic treatment: 1 hollow of the hand* for a friction time of 30 sec.
Surgical disinfection: 2 x 1 hollow of the hand* for a friction time of twice 45
sec. Correctly apply the product until hands are completely dry.
Do not rinse.
For application in the operating room and for frequency of use, refer to the
Establishment's protocol.
(* 1 hollow of the hand = 3 ml minimum)

OTHER SAFETY INFORMATION

Other information
Does not require water
Store at 41 - 77 °F (5 - 25 °C)
Do not reuse the packaging.
Dispose of the product and its container as hazardous waste.
Store in a well-ventilated place

INACTIVE INGREDIENT

Inactive ingredients
Moisturizers, thickeners and water.

QUESTIONS

Questions or comments?
Call (800)726-2308 Monday/Friday 9:00am to 5:00pm

PRINCIPAL DISPLAY PANEL

DRUG FACTS

Main Display

INGREDIENTS AND APPEARANCE

ANIOSGEL 85  NPC
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62169-203
Route of Administration	TOPICAL

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	03/07/2018
1	NDC: 62169-203-17	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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 (268309216)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Anios		268309216	manufacture(62169-203) , label(62169-203)