HAND SANITIZER- alcohol gel 
Monarch Global Brands, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer

Active Ingredient

Ethyl Alcohol 62% v/v. Purpose: Antibacterial

Purpose

Antibacterial, Hand Sanitizer

Use[s]

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

Other information

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)

PDP

355mL NDC: 80330-007-02

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

12 oz. (355ml)

PDP

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

PDP

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80330-001(NDC:74742-007)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80330-001-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
2NDC:80330-001-02355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
3NDC:80330-001-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/27/2020
Labeler - Monarch Global Brands, Inc. (014623185)

Revised: 8/2020
Document Id: adeaad60-8e5e-7482-e053-2995a90ac688
Set id: adea8ad3-d476-07a0-e053-2a95a90a1799
Version: 1
Effective Time: 20200827
 
Monarch Global Brands, Inc.