NON-STERILE HAND SANITIZER- alcohol gel

Non-Sterile Hand Sanitizer by

Drug Labeling and Warnings

Non-Sterile Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HR Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active ingredient

Ethyl Alcohol 70%

​Purpose

Antiseptic

​Use:

Hand sanitizer to help reduce bacteria on the skin

​Warnings:

Flammable.  Keep away from fir or flame. For external use only.

• When using this product do not use in or near the eyes.  In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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.
• Supervise 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)

​Inactie Ingredients:

Water (Aqua), Glycerin, Carbomer, Aloe Barbadensis Leaf Juice, Sodium Hydroxide

Package Labeling:

INGREDIENTS AND APPEARANCE

NON-STERILE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69464-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69464-001-03	1728 in 1 BOX	03/26/2020
1		3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/26/2020

Labeler - HR Pharmaceuticals, Inc. (117164328)

Establishment
Name	Address	ID/FEI	Business Operations
HR Pharmaceuticals, Inc.		117164328	manufacture(69464-001)