HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MedZone Products, LLC, Hubot Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

• ANTISEPTIC HANDWASH
• DAILY USE, TRAVEL,
  & SPORTS
• RINSE FREE

OF COMMON ILLNESS CAUSING GERMS
KILLS
99.99%
IN 15 SECONDS

16 FL OZ (473mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	0.625 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-604-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2020

Labeler - MedZone Products, LLC (080083739)

Establishment
Name	Address	ID/FEI	Business Operations
Hubot Healthcare LLC		081084880	MANUFACTURE(70338-604)