Fiori Gallon Hand Sanitizer by International Merchandise Group / Distribuidora Cuscatlan

Fiori Gallon Hand Sanitizer by

Drug Labeling and Warnings

Fiori Gallon 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 GALLON 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.

----------

Ethyl alcohol 70 %

Do Not store above 105 F may discolor some fabrics finishes and plastics For hands external use only

Flammable, keep away from fire or flame.

For Hands external use only Wet hands thoroughly with product and allow to dry withou wiping. For children under 6 use only under adult supervision not recommended for infants.

For Hands external use only

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 appears or if condition persists for more then 72 hours,

Keep out of reach of children if swallowed, get medical help or contact a poison control right away.

Aqua / Water Acrylates / c 10 30 alkyl Acrylate Crosspolymer , Carbomer Aminomethyl propanol

Aminomethylpropanol

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

For Hands external use only Wet hands thoroughly with product and allow to dry without wiping. For children under 6 use only under adult supervision not recommended for infants.

For Hands external use only Wet hands thoroughly with product and allow to dry without wiping. For children under 6 use only under adult supervision not recommended for infants.

FIORI GALLON HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73971-199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73971-199-01	3780 mL in 1 JUG; Type 0: Not a Combination Product	07/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020	12/31/2021

Labeler - International Merchandise Group (555630446)

Establishment
Name	Address	ID/FEI	Business Operations
International Merchandise Group		555630446	label(73971-199)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Cuscatlan		851247924	manufacture(73971-199)

Revised: 1/2022

Document Id: d64741db-01c5-3382-e053-2a95a90a4648

34390-5

Set id: abacde6d-aa9e-e5da-e053-2995a90aa73c

Version: 3

Effective Time: 20220123