THEORIE ANTIMICROBIAL HAND WASH- benzalkonium chloride soap

Theorie Antimicrobial Hand WASH by

Drug Labeling and Warnings

Theorie Antimicrobial Hand WASH 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%

Uses

For hand washing to decrease bacteria that can potentially cause disease.

Warnings

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

KEEP OUT OF REACH OF CHILDREN

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

For maximum efficiency, pump the product into wet hands, lather vigorously, sinse and dry.

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Coco Glucoside, Glycerin, Polysorbate-20, PEG-150 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Sodium Hyaluronate, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, 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 ANTIMICROBIAL HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73857-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.0013 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGAN OIL (UNII: 4V59G5UW9X)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73857-003-00	0.400 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/14/2020

Labeler - Dynastis, LLC (021238554)

Registrant - Dynastis, LLC (021238554)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(73857-003) , relabel(73857-003) , pack(73857-003)