CLASSY HAND SANITIZER- alcohol gel 
Ester Co., Ltd.

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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ACTIVE INGREDIENT

Active ingredients: ALCOHOL 70%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Carbomer, Tetrahydroxypropyl Ethylenediamine, Fragrance, Aloe Arborescens Leaf Extract, Butylene Glycol

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

Flammable, Keep away from fire or flame


For external use only

When using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep our of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Uses

Uses:

For handwashing when water is not available to decrease bacteria on the skin
- After changing diapers
-  After assisting ill persons
-  Before contact with a person under medical care or treatment
-  Recommended for repeated use

Directions

Directions:

-  Apply palmful to hands
-  Rub hands together vigorously until dry
-  Supervise children in the use of this product

Other Information

Other Information:
Store at room temperature: 15°~30 °C (59°~86 °F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

CLASSY HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETOL (UNII: Q4R969U9FR)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74004-060-01500 mL in 1 BOTTLE, PUMP; 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 - Ester Co., Ltd. (688425766)
Registrant - Ester Co., Ltd. (688425766)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd.688425766manufacture(74004-060)

Revised: 11/2020
Document Id: b3e0bc1d-211e-c005-e053-2a95a90a89d6
Set id: 8e8288a8-ba76-4c36-94e2-f0c4dfd19850
Version: 2
Effective Time: 20201111
 
Ester Co., Ltd.