HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Commercial Beverage Concepts, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT [S]

ALCOHOL 70% v/v

PURPOSE

ANTISEPTIC

USE[S]

Health care personnel hand rub to help reduce baceria that potentionally can cause disease.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

• In children less than 2 months of age.
• On open skin wounds.

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.

DIRECTIONS

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Suprevise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C 104F

INACTIVE INGREDIENTS

PEG-6 & AMP, Glycerin, Acrylates / Vinyl Isodecanoate Crosspolymer, Tocopheryl Acetate, Isopropyl Myristate, Fragrance (Parfum).

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75594-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75594-170-12	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - Commercial Beverage Concepts, LLC (080925174)