Fiori Hand Sanitizer by International Merchandise Group / Distribuidora Cuscatlan

Fiori Hand Sanitizer by

Drug Labeling and Warnings

Fiori Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by International Merchandise Group, Distribuidora Cuscatlan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIORI HAND SANITIZER- alcohol gel 
International Merchandise Group

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.

----------

Warnings

Do not store above 105 F . may discolor some fabrics.

Harmful to wood finishes and plastics.

For external use only

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 and redness apperas or if condition persists for more then 72 hours.

Inactive ingredients

AQUA / WATER, ACRYLATES/ C10-30 ALKYL ACRYLATE CROOSPOLYMER, CARBOMER,

AMINOMETHYL PROPANOL.

Purpose

To decrease bacterias on the skin that could cause disease. Recomended for repeated use.

Administration

For Hands external use only

Wet hand thoroughly with product and allow to dry withou wiping. For children under 6, use only under adult supervisio.Not recommended for infants.

keep out of reach of children

Keep out of reach of children.

if swallowed, get medical help or contact a poison control center right away.

Active ingredient

Ethyl Alcohol 70 %

Indications

to decrease bacterias on the skin that could cause disease. Recommended for repeated use.

Package Principal Front & Back

Front & Back

FIORI HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73971-195
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 70 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73971-195-01480 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/22/202012/31/2021
Labeler - International Merchandise Group (555630446)
Establishment
NameAddressID/FEIBusiness Operations
International Merchandise Group555630446label(73971-195)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Cuscatlan851247924manufacture(73971-195)

Revised: 1/2022
Document Id: d64754f1-c11f-bf05-e053-2995a90ad892
Set id: ab019b5a-70bf-6355-e053-2a95a90af7fe
Version: 2
Effective Time: 20220123