FLORANCE MORRIS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

Florance Morris Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Florance Morris Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Asimex International Llc, Grupo Asimex de México, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

■To decrease bacteria on the skin that could cause disease

■Recommended for repeated use

Warnings

For external use only: hands.

■Flammable ■Keep away from fire or flame

When using this product ■Keep out of eyes ■In case of contact with eyes, flush thoroughly with water ■Avoid contact with broken skin ■Do not inhale or ingest

Stop use and ask a doctor if ■Irritation or redness develops. ■Condition persists 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

Thoroughly cover your hands with product and allow to dry without wiping ■Children under 6 years of age should be supervised when using this product ■Not recommended for infants

Other information

Store below 105°F ■May discolor some fabrics ■Harmful to wood finishes and plastics

Inactive ingredients

Cellulosic thickener, Glycerin, Triethanolamine, Water

QUESTIONS

Questions? +1-786-843-1308
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Florance Morris

body care

Distributed by: Asimex International LLC

9100 S Dadeland Blvd,

Ste 912 Miami, FL, 33156

COUNTRY OF ORIGIN: MEXICO

Lot No:

Expiry:

Packaging

INGREDIENTS AND APPEARANCE

FLORANCE MORRIS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76612-180
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76612-180-12	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
2	NDC: 76612-180-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
3	NDC: 76612-180-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
4	NDC: 76612-180-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
5	NDC: 76612-180-37	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/23/2020

Labeler - Asimex International Llc (025004798)

Establishment
Name	Address	ID/FEI	Business Operations
Grupo Asimex de México, S.A. de C.V.		812962512	manufacture(76612-180)