Theorie Signature Fragrances Moroccan Fig nourishing hand wash

Theorie Moroccan Fig nourishing hand wash by

Drug Labeling and Warnings

Theorie Moroccan Fig nourishing 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]

THEORIE MOROCCAN FIG NOURISHING HAND WASH- benzalkonium chloride soap 
Dynastis, 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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Theorie Signature Fragrances Moroccan Fig nourishing hand wash

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

Do not use

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

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.

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, 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

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

THEORIE MOROCCAN FIG NOURISHING HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73857-005
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)
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: 73857-005-00	0.400 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2021	12/31/2023

Labeler - Dynastis, LLC (021238554)

Registrant - Dynastis, LLC (021238554)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(73857-005) , label(73857-005) , pack(73857-005)

Revised: 1/2023

Document Id: dd16fbf4-072b-4c55-9df3-e5b52a96d220

34390-5

Set id: 0221e59d-7e9a-4a17-8a35-091f2abbca68

Version: 3

Effective Time: 20230111