FLORANCE MORRIS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
Asimex International Llc

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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Florance Morris body care ANTISPETIC HAND SANTITIZER

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

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

image description

FLORANCE MORRIS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76612-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76612-180-12125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
2NDC:76612-180-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
3NDC:76612-180-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
4NDC:76612-180-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
5NDC:76612-180-374000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/23/2020
Labeler - Asimex International Llc (025004798)
Establishment
NameAddressID/FEIBusiness Operations
Grupo Asimex de México, S.A. de C.V.812962512manufacture(76612-180)

Revised: 5/2020
Document Id: f2327d8f-195c-47b2-8198-179dbd1c8ce5
Set id: ea665ce2-80ae-43bb-ba01-9f49cc4df997
Version: 1
Effective Time: 20200504
 
Asimex International Llc