HAND SANITIZER- alcohol gel 
MedZone Products, LLC

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

DRUG FACTS

Active Ingredient

Ethyl Alcohol 62.5% v/v

Purposes

Antiseptic handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only | Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

Do not use

In eyes | In children less than 2 months of age | On open skin wounds

When using this product

If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness develops

Stop use and ask a doctor

If irritation or rash occurs. These may be signs of a serious condition

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

For additional information, see Safety Data Sheets (SDS) | For emergency medical information in USA and Canada, call 1-888-255-3924 | For emergency medical information worldwide, call 1-813-248-0573 | Store between 15-30°C (59-86°F) | Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Water (Aqua), Propylene Glycol, Dimethicone Peg-7 Isostearate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanediol, Tocopherol Acetate, Aloe Barbadensis Leaf Juice

Questions?

Toll Free 866-MEDZONE (866-633-9663) www.medzonecorp.com | info@medzonecorp.com

DISTRIBUTED BY
MedZone Products LLC

9300 Marshall Dr, Ste. 200,
Lenexa, Kansas 66215 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

MedZone®
SINCE 2001

Hand
Sanitizer

GEL

MADE IN USA

OF COMMON ILLNESS CAUSING GERMS
KILLS
99.99%
IN 15 SECONDS

16 FL OZ (473mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.625 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Dimethicone Peg-7 Isostearate (UNII: JVS3399FNW)  
Aminomethyl propanediol (UNII: CZ7BU4QZJZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70338-604-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2020
Labeler - MedZone Products, LLC (080083739)
Establishment
NameAddressID/FEIBusiness Operations
Hubot Healthcare LLC081084880MANUFACTURE(70338-604)

Revised: 3/2020
Document Id: 2ca74bc8-81cc-48be-8e7e-7c5488c2edb4
Set id: 630f325f-e8a0-4de8-944e-bb048b0033a0
Version: 1
Effective Time: 20200326
 
MedZone Products, LLC