ALCOHOL ANTISEPTIC 71 ANTISEPTIC HAND RUB NON STERILE- alcohol gel

Alcohol Antiseptic 71 Antiseptic Hand Rub Non sterile by

Drug Labeling and Warnings

Alcohol Antiseptic 71 Antiseptic Hand Rub Non sterile by is a Otc medication manufactured, distributed, or labeled by Magnekon, S.A. De C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient[s]

Ethyl Alcohol 71% v/v

Purpose

Antiseptic

Use[s]:

Health care personnel hand rub to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings:

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing

Other information:

Store between 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients:

Purified water, Acrylates C10-30 Alkyl Acrylate Copolymer, Glycerin, and Triclosan.

Package Labeling:

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 71 ANTISEPTIC HAND RUB NON STERILE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77825-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.71 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TRICLOSAN (UNII: 4NM5039Y5X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77825-000-00	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - Magnekon, S.A. De C.V. (812418473)

Establishment
Name	Address	ID/FEI	Business Operations
Magnekon, S.A. De C.V.		812418473	manufacture(77825-000) , label(77825-000) , pack(77825-000)