ZEPOL- ethyl alcohol gel

ZEPOL by

Drug Labeling and Warnings

ZEPOL by is a Otc medication manufactured, distributed, or labeled by DILE ENTERPRISES LLC, DILE ENTERPRISE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

PURPOSE

Antisptic, Hand Sanitizer

WARNINGS

Flammable. Keep awy from fire or flame. For external use.

DO NOT USE

In children less than 2 months of age

On open skin wounds

WHEN USING

Do not use in eyes. In case of contact with eyes, rinse with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help promptly.

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surface. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

STORAGE AND HANDLING

Store between 15-30C (59-89F)

INDICATIONS & USAGE

For handwashing to decrease bacteria for the skin.

INACTIVE INGREDIENT

Water, carbomer, isopropyl alcohol, triethanolamine

PRINCIPAL DISPLAY PANEL

3.785L NDC: 79198-656-01

INGREDIENTS AND APPEARANCE

ZEPOL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79198-656
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FENOPROP TRIETHANOLAMINE (UNII: 2F3CU8K84U)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79198-656-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/22/2020

Labeler - DILE ENTERPRISES LLC (117555202)

Establishment
Name	Address	ID/FEI	Business Operations
DILE ENTERPRISE LLC		117555202	manufacture(79198-656)