PRIMAGEL PLUS RINSE-FREE ANTISEPTIC HAND SANITIZER 70 ETHYL ALCOHOL- alcohol gel

Primagel Plus Rinse-Free Antiseptic Hand Sanitizer 70 Ethyl Alcohol by

Drug Labeling and Warnings

Primagel Plus Rinse-Free Antiseptic Hand Sanitizer 70 Ethyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Allegrini SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 in a cool place, away from sources of heat.

Inactive ingredients

Water, glycerin, propylene glycol, aloe vera leaf juice, methyl gluceth-20, carbomer, aminomethyl propanol, citric acid, fragrance, sodium benzoate, potassium sorbate, limonene, citral, geraniol

Package Labeling:80899-001-01

Package Labeling:80899-001-02

Package Labeling:80899-001-03

Package Labeling:80899-001-04

INGREDIENTS AND APPEARANCE

PRIMAGEL PLUS RINSE-FREE ANTISEPTIC HAND SANITIZER 70 ETHYL ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80899-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80899-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2021
2	NDC: 80899-001-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2021
3	NDC: 80899-001-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2021
4	NDC: 80899-001-04	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2021

Labeler - Allegrini SPA (429407935)