ALCOHOL FOAMING HAND SANITIZER- alcohol liquid

Alcohol Foaming Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cintas Corp., Best Sanitizers, Inc, Natural Essentials Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                               

Ethyl Alcohol 62%

INDICATIONS & USAGE

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

WARNINGS

Warnings

Flammable. Keep away from fire or flames.

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if conditions 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.

DOSAGE & ADMINISTRATION

Directions:

Wash hands with soap and water

Rinse with potable water

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

STORAGE AND HANDLING

Other Information:

Store below 110 F (43 C)

May discolor certain fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredient

DEA-C8-18 perfluoroalkylethyl phosphate, Glycerin, Isopropyl alcohol, Water

PURPOSE

Purpose

Antimicrobial

PRINCIPAL DISPLAY PANEL

Sanis

Alcohol Foaming

Hand

Sanitizer

800 ML 27.0 FL OZ

INGREDIENTS AND APPEARANCE

ALCOHOL FOAMING HAND SANITIZER  
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-005-02	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020
2	NDC: 42961-005-06	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2009

Labeler - Cintas Corp. (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials Incorporated		947484713	manufacture(42961-005)

Establishment
Name	Address	ID/FEI	Business Operations
Avmor		202107827	manufacture(42961-005)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers, Inc		627278224	manufacture(42961-005)