SANIFECT E3 PLUS HAND SANITIZER- ethyl alcohol liquid

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS
ACTIVE INGREDIENT

Active Ingredients: Ethyl Alcohol 80%
PURPOSE

Purpose: Antiseptic
INDICATIONS & USAGE

Uses Hand wash to help reduce bacteria on skin that potentially can cause diseases. Helps prevent cross contamination by hand contact
Helps prevent drying and chafing of skin Recommended for repeat use
WARNINGS

Warnings
For external use only
OTHER SAFETY INFORMATION

Flammable, keep away from fire or flame.
WHEN USING

When using this product do not use in or near eyes. Discontinue use if irritation or redness develops. Use in well-ventilted area.
STOP USE

Stop use and ask a doctor if irritation persists for more than 72 hours.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
DOSAGE & ADMINISTRATION

Directions:

Place a palmful of product in one hand Spread on both hands
and rub into the skin until dry (1-2 min.) No rinsing or toweling
requiredoweling required.
OTHER SAFETY INFORMATION

Other Information:

Store in a cool dry place below 104°F Recommended for use in
AFCO Systems For Food Processing, Food Service and
Professional Use Only Use Only.
INACTIVE INGREDIENT

Inactive Ingredients:

Water, isopropyl alcohol, glycerin, hydrogen peroxide, tertiary butyl alcohol*, denatonium benzoate*, citric acid*

*Contains one or more of these ingredients.
QUESTIONS

Questions or Comments:

For product or technical information, contact AFCO Monday to Friday 8 AM to 4 PM EST at 1-800-345-1329 or visit our website at www.afcocare.com
Product Package Labeling

AFCO 5324

Sanifect E3 Plus
Hand Sanitizer

UN 1170, ETHANOL
SOLUTIONS, 3, PG II,
ER GUIDE NO. 127

CHEMTREC EMERGENCY 800-424-9300

(Chemtrec Customer Number: CCN837)

MANUFACTURED BY:
ALEX C. FERGUSSON
800 DEVELOPMENT AVENUE
CHAMBERSBURG, PA 17201
TOLL FREE: 800-345-1329

NDC# 68776-1009-1
BATCH NO.:
EXP. DATE:
CONTENTS: 1 GALLON

HMIS HAZARD RATING

HEALTH                                   1

FLAMMABILITY                    3

REACTIVITY                          0

PERSONAL PROTECTION   A

1 Gal.

5 Gal.

55 Gal.

1000 mL

30 Gal.

res

SANIFECT E3 PLUS HAND SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68776-1009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 68776-1009-1	4 in 1 CASE	04/27/2020
1		3.8 L in 1 JUG; Type 0: Not a Combination Product
2	NDC: 68776-1009-2	18.9 L in 1 JUG; Type 0: Not a Combination Product	04/27/2020
3	NDC: 68776-1009-3	208.2 L in 1 DRUM; Type 0: Not a Combination Product	04/27/2020
4	NDC: 68776-1009-4	6 in 1 PACKAGE	04/27/2020
4		1 L in 1 CARTRIDGE; Type 0: Not a Combination Product
5	NDC: 68776-1009-5	113.6 L in 1 DRUM; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/27/2020

Labeler - Alex C. Fergusson, Inc. (604091413)

Registrant - Alex C. Fergusson, Inc. (604091413)

Name	Address	ID/FEI	Business Operations
Establishment
Alex C. Fergusson, Inc.		798583154	manufacture(68776-1009) , label(68776-1009) , pack(68776-1009)

SANIFECT E3 PLUS HAND SANITIZER- ethyl alcohol liquid

Sanifect E3 Plus Hand Sanitizer by

Drug Labeling and Warnings

Drug Details [pdf]