HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Monarch Global Brands, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 62% v/v. Purpose: Antibacterial

Purpose

Antibacterial, Hand Sanitizer

Use[s]

• Hand Sanitizer to reduce bacteria on the skin
• Recommended for repeated use

Warnings

Flammable., keep away from fire and flame

For external use only

When using this product

do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult doctor

if irritation occurs or rash appears and lasts.

Keep out of reach of Children.

If swallowed, get medical help or call a Poison Control Center.

Directions

• Place enough product in your palm to cover your hands
• Rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Other information

• Store below 106F (41C)
• May discolor certain fabrics or surfaces
• Avoid freezing and heat above 105F (40C)

Inactive ingredients

water, glycerin，triethanolamine,carbomer, Aloe Barbadensis Leaf extract, Tocopheryl Acetate

Questions or Comments?

215 482 6100

info@monarchbrands.com

Package Label - Principal Display Panel

237mL NDC: 80330-007-01

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

8 oz. (237ml)

355mL NDC: 80330-007-02

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

12 oz. (355ml)

3785mL NDC: 80330-007-03

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

1 U.S. Gallon

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80330-001(NDC:74742-007)
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80330-001-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020
2	NDC: 80330-001-02	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020
3	NDC: 80330-001-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/27/2020

Labeler - Monarch Global Brands, Inc. (014623185)