THEORIE ANTI-MICROBIAL INSTANT HAND SANITIZER- benzalkonium chloride 0.13% gel

THEORIE Anti-Microbial Instant Hand Sanitizer by

Drug Labeling and Warnings

THEORIE Anti-Microbial Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dynastis, LLC, Cosco International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Benzalkonium Chloride 0.13% - Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings:

For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children

Do not use:

in children less than 2 months of age
on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Children must be supervised when using this product.

INDICATIONS & USAGE

Stop use and ask a doctor if: irritation or rash occurs. These maybe signs of a serious condition.

Directions:

Place one pump quantity of the product in you palm and rub your hands entirely until product is completely absorbed and dry. Children must be supervised when using this product.

Inactive Ingredients:

Water, Glycerin, Propanediol, Hydroxyethylcellulose, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, PEG-12 Dimethicone, Guar Hydroxypropyltrimonium Chloride, Sodium Hyaluronate, Argania Spinosa Kernel (Argan) Oil, Tocopheryl Acetate, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat.
You may report a serious adverse reaction to: Hautehouse, LLC, 909 NW Terrace, Fort Lauderdale, FL 33311 USA

For Questions:

HAUTEHOUSE INC.
909 NW Terrace
Fort Lauderdale, FL 33311 USA
+1 (954) 376-8966
www.hautehouse.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THEORIE ANTI-MICROBIAL INSTANT HAND SANITIZER 
benzalkonium chloride 0.13% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73857-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73857-002-00	0.420 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Dynastis, LLC (021238554)

Registrant - Dynastis, LLC (021238554)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc		016433141	manufacture(73857-002) , relabel(73857-002) , pack(73857-002)