PURPLE MOUNTAIN CLEAN HAND SANITIZER- isopropyl alcohol, ethyl alcohol gel 
Edison Nation, 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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PURPLE MOUNTAIN CLEAN HAND SANITIZER

DRUG FACTS

Active Ingredients: 

Isopropyl Alcohol 60% v/v

Ethyl Alcohol 10% v/v

Purpose:

antiseptic

Uses: 

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are unavailable.

Warnings:

For external use only. Flammable. Keep away from heat and flame, avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Stop use and askdoctor if irritation or redness develops, or if condition persists for more than 72 hours

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. For children under 6, use with adult supervision. Not recommended for infants.

Other info:

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

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

Inactive Ingredients:

Carbomer, ethanolamine, polyethylene glycol, water USP, Fragrance.

Refreshing Gel

Made in the USA

Kills more than 99.9% of germs

70%alcohol

60% Isopropyl /10% Ethyl

100% SATISFACTION 

GUARANTEED

Distributed by:

GLOBAL CLEAN SOLUTIONS

WARNING

Extremely flammable

Packaging

Purple2

PURPLE MOUNTAIN CLEAN HAND SANITIZER 
isopropyl alcohol, ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80120-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL60 L  in 100 L
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL10 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80120-101-003.785 L in 1 JUG; Type 0: Not a Combination Product08/17/2020
2NDC:80120-101-160.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/17/2020
Labeler - Edison Nation, Inc. (081181069)

Revised: 8/2020
Document Id: 711fe64d-6237-4c3c-aa83-ee08ebd566af
Set id: 59e2501d-e087-4904-957a-e41130e1370f
Version: 1
Effective Time: 20200819
 
Edison Nation, Inc.