INSTANT HAND SANITIZER- alcohol liquid

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cintas Corp., Natural Essentials Incorporated, Best Sanitizers, Inc. 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 flame.

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:

Pump enough product in palm of hand to thoroughly cover all surfaces of both hands.

Rub hands together briskly until dry.

INACTIVE INGREDIENT

Inactive Ingredients:

Acrylates/C10-30 alkyl acrylate crosspolymer, Fragrance, Glycerin, Isopropyl alcohol, Isopropyl myristate, Propylene glycol, Triisopropanol amine, Tocopheryl acetate, Water

PURPOSE

Purpose

Antimicrobial

STORAGE AND HANDLING

Other Information:

Store below 110 F (43 C)

PRINCIPAL DISPLAY PANEL

Sanis

Instant

Hand

Sanitizer

800 ML 27.0 FL OZ

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER  
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-002
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)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-002-03	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020
2	NDC: 42961-002-04	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020
3	NDC: 42961-002-07	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020
4	NDC: 42961-002-08	3 mL in 1 TUBE; 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	04/22/2008

Labeler - Cintas Corp. (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials Incorporated		947484713	manufacture(42961-002)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers, Inc		627278224	manufacture(42961-002)