Antiseptic Hand Sanitizer Gel for Life

Antiseptic Hand Sanitizer Gel for Life by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer Gel for Life by is a Otc medication manufactured, distributed, or labeled by GFL SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND SANITIZER GEL FOR LIFE- alcohol gel 
GFL SA

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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Antiseptic Hand Sanitizer Gel for Life

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes

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

Other information

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

Inactive ingredients

Water (aqua), glycerin, acrylates copolymer, aminomethyl propanol, carbomer.

Package Labeling: 370 mL

Package Labeling: 46mL

Package Labeling: 100mL

ANTISEPTIC HAND SANITIZER GEL FOR LIFE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77513-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77513-002-01	370 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020	07/10/2023
2	NDC: 77513-002-02	46 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020	07/10/2023
3	NDC: 77513-002-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020	07/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2020	07/10/2023

Labeler - GFL SA (486270809)

Revised: 10/2021

Document Id: cdafdcb0-3fe0-8e49-e053-2995a90abab0

34390-5

Set id: 391c333e-b086-44cc-8c34-b4ab3941aeb7

Version: 2

Effective Time: 20211006