PRISTINE CLEAN HAND SANITIZER- MEDICAL GRADE- ethyl alcohol liquid 
High Mark Distillery, Inc. DBA: High Mark Barrel House, 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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HIGH MARK DISTILLERY PRISTINE CLEAN MEDICAL GRADE HAND SANITIZER

DRUG FACTS:

ACTIVE INGREDIENTS:

Denatured Ethyl Alcohol ABV 80%

PURPOSE:

Antiseptic

USES: Sanitizer to decrease bacteria on the skin. May decrease up to 99.99% of Viruses on contact when properly used.

DIRECTIONS: ​Wet hands thoroughly with sanitizer. Briskly rub hands together until dry. Supervise children under 6 years in use of sanitizer.

WARNINGS: FLAMMABLE- Do not use near heat, fire, flame, or while smoking. Do not store where temperature exceeds 105 Degrees F. May discolor certain fabrics.

FOR EXTERNAL USE ONLY: DO NOT GET IN EYES. In case of eye contact flush thoroughly with water. Do not inhale or ingest. If swallowed, get medical help, and drink water to flush out of system. Stop use and ask a doctor if skin irritation develops.

DO NOT USE ON: Burns or Open Wounds

KEEP OUT OF REACH OF CHILDREN: ​If swallowed, get medical help immediately, and drink water to flush out of system.

INACTIVE INGREDIENTS: ​Distilled Water, Hydrogen Peroxide, Glycerin, Plant Food Color-Blue.

HANDCRAFTED IN AMERICA* AMERICAN SPIRITS, CROPS, AND WORKERS

HIGH MARK DISTILLERY

100% MADE IN USA

Produced and Bottled by: High Mark Distillery; Inc. Reno, NV

WWW.highmarkdistillery.com

Packaging

IMAGE

PRISTINE CLEAN HAND SANITIZER- MEDICAL GRADE 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78288-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78288-201-0388.7 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
2NDC:78288-201-08236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
3NDC:78288-201-12360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/21/2020
Labeler - High Mark Distillery, Inc. DBA: High Mark Barrel House, Inc. (057681428)
Establishment
NameAddressID/FEIBusiness Operations
High Mark Distillery, Inc. DBA: High Mark Barrel House, Inc.057681428manufacture(78288-201)

Revised: 6/2020
Document Id: 9460793d-4a22-4600-8e1e-b0bf650ab247
Set id: 7020bba5-bb40-408f-91e6-52afb2f9fddf
Version: 1
Effective Time: 20200609
 
High Mark Distillery, Inc. DBA: High Mark Barrel House, Inc.