FOAMING HAND SANITIZER- alcohol aerosol, foam

Foaming Hand Sanitizer by

Drug Labeling and Warnings

Foaming 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

Purpose

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 | Contents under pressure. Do not store at temperatures above 120°F (48°C), puncture or incinerate. | Operate only with spout pointing down.

Do not use

In eyes

When using this product

If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness develop, stop use and ask a doctor if skin irritation or redness occur 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

Spread thoroughly onto hands and rub until dry.

Other

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

Inactive Ingredients

Water, Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Steareth-20, Sodium Benzoate, Propane, Cetyl Lactate, Sodium Sesquicarbonate

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 Drive, Ste. 200
Lenexa, Kansas 66215

PRINCIPAL DISPLAY PANEL - 44 mL Can Label

MedZone®
SINCE 2001

Foaming
Hand
Sanitizer

HOSPITAL STRENGTH

MADE IN USA

• SOFTENS SKIN &
  PREVENTS DRYNESS
• HYPO ALLERGENIC
• ANTISEPTIC HANDWASH
• RINSE FREE

KILLS
99.99%
OF COMMON ILLNESS CAUSING GERMS
IN 15 SECONDS

1.5 FL OZ (44mL)

INGREDIENTS AND APPEARANCE

FOAMING HAND SANITIZER 
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
Isobutane (UNII: BXR49TP611)
Steareth-20 (UNII: L0Q8IK9E08)
Sodium Benzoate (UNII: OJ245FE5EU)
Propane (UNII: T75W9911L6)
Cetyl Lactate (UNII: A7EVH2RK4O)
Sodium Sesquicarbonate (UNII: Y1X815621J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-602-70	44 mL in 1 CAN; Type 0: Not a Combination Product	05/15/2020
2	NDC: 70338-602-80	236 mL in 1 CAN; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2020

Labeler - MedZone Products, LLC (080083739)

Establishment
Name	Address	ID/FEI	Business Operations
Hubot Healthcare LLC		081084880	MANUFACTURE(70338-602)