IRIS HAND SANITIZER GEL- alcohol gel

Hand Sanitizer IPA Gel by

Drug Labeling and Warnings

Hand Sanitizer IPA Gel by is a Otc medication manufactured, distributed, or labeled by Iris LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only. Flammable. Keep away from heat and flame.

DO NOT USE

In children less than two months of age

On open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Glycerin, propylene glycol, carbomer, aminomethylproponal, purified water USP

PRINCIPAL DISPLAY PANEL

8 FL OZ (237 ML)

INGREDIENTS AND APPEARANCE

IRIS HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74052-337
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74052-337-10	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Iris LLC (114973408)

Establishment
Name	Address	ID/FEI	Business Operations
Iris LLC		114973408	manufacture(74052-337)