GOLDEF ANTISEPTIC HAND SANITIZER- alcohol liquid

GOLDEF ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

GOLDEF ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by MEDIPROMTECH, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin  recommended for repeated use  for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use  in children less than 2 months of age  on open skin wounds

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if 

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

wet hands thoroughly with product and allow to dry without wiping  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

water, hydrogen peroxide, glycerin

Questions?

+1-404-795-4774

You may also report serious effectsto this phone number.

Mon-Fri 9:00AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%

Topical solution  Non-Sterile Solution

Moisturising

Manufactured by: MEDIPROMTECH LLC

Stelmaha 9, Irpin city, Ukraine 08205

COUNTRY OF ORIGIN: UKRAINE

info@goldef.ua

www.goldef.ua

Lot. No

Expiry

Packaging

INGREDIENTS AND APPEARANCE

GOLDEF ANTISEPTIC HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79553-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79553-101-20	80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020
2	NDC: 79553-101-30	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020
3	NDC: 79553-101-40	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020
4	NDC: 79553-101-50	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020
5	NDC: 79553-101-60	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020
6	NDC: 79553-101-70	5000 mL in 1 CANISTER; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - MEDIPROMTECH, LLC (520862497)

Establishment
Name	Address	ID/FEI	Business Operations
MEDIPROMTECH, LLC		520862497	manufacture(79553-101)