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 70%

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin

  recommended for repeated use

  for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

in children less than 2 months of age

on open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctorif

irritation and redness develop

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

wet hands thoroughly with product and allow to dry without wiping 

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

Other information

store between 15-30°C (59-86°F) 

avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydroxyethylcellulose, triethanolamine, water

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

Packaging

INGREDIENTS AND APPEARANCE

FLORANCE MORRIS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76612-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 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: 76612-170-12	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
2	NDC: 76612-170-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
3	NDC: 76612-170-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
4	NDC: 76612-170-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
5	NDC: 76612-170-37	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(76612-170)