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 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

Florance Morris

body care

Distributed by: Asimex International LLC

9100 S Dadeland Blvd, Ste 912 Miami, FL, 33156

COUNTRY OF ORIGIN: MEXICO

Packaging

image description

FLORANCE MORRIS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76612-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 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:76612-170-0660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
2NDC:76612-170-11120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
3NDC:76612-170-12125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
4NDC:76612-170-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
5NDC:76612-170-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
6NDC:76612-170-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
7NDC:76612-170-374000 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(76612-170)

Revised: 6/2020
Document Id: 448eb2b6-2840-42bf-8259-68297b5825d0
Set id: 9506050b-ee40-40f8-ad34-d9bbaf51c388
Version: 3
Effective Time: 20200601
 
Asimex International Llc