PRIMEGEL ANTISEPTIC HAND SANITIZER GEL 80 ETHYL ALCOHOL- alcohol gel

PrimeGel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol by

Drug Labeling and Warnings

PrimeGel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol by is a Otc medication manufactured, distributed, or labeled by FIGUEIRA E FELICIANO INDUSTRIA DE COSMETICOS LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 80%

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

• Do not store above 104°F (40°C). 
• Keep the container tightly closed in a cool, well-ventilated place.

Inactive ingredients

Carbomer, glycerin, hydrogen peroxide, triethanolamine, water

Package Labeling:

INGREDIENTS AND APPEARANCE

PRIMEGEL ANTISEPTIC HAND SANITIZER GEL 80 ETHYL ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81717-001
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81717-001-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2021

Labeler - FIGUEIRA E FELICIANO INDUSTRIA DE COSMETICOS LTDA (903595328)