ICELAND FIRMING WATERY CREA M by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co., Ltd.

ICELAND FIRMING WATERY CREA M by

Drug Labeling and Warnings

ICELAND FIRMING WATERY CREA M by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ICELAND FIRMING WATERY CREA M- dimethicone cream 
NATURE REPUBLIC CO., LTD.

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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ACTIVE INGREDIENT

Active ingredients: DIMETHICONE 4.16%

INACTIVE INGREDIENT

Inactive ingredients: Water, Dicaprylyl Ether, Glycerin, Isononyl Isononanoate, Dipropylene Glycol, Water, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Macadamia Ternifolia Seed Oil, Cetearyl Alcohol, Polysorbate 60, Glyceryl Stearate, Peg-100 Stearate, Butylene Glycol, Sorbitan Stearate, Squalane, Fragrance, Glyceryl Stearate Se, Xanthan Gum, Algae Extract, Eclipta Prostrata Leaf Extract, Hydrogenated Polyisobutene, Peg-150 Distearate, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alcohol, Rhododendron Ferrugineum Extract, Pseudoalteromonas Ferment Extract, Amaranthus Caudatus Seed Extract, Ulmus Davidiana Root Extract, Lepidium Meyenii Root Extract, Hydrogenated Lecithin, Argania Spinosa Kernel Oil, Polyglyceryl-10 Stearate, Adenosine, Fructooligosaccharides, Polyglyceryl-2 Dipolyhydroxystearate, Stearic Acid, Sorbitan Laurate, Beta-Glucan, Lecithin, Carbomer, Disodium Edta, Hydrolyzed Hyaluronic Acid, Inulin Lauryl Carbamate, Hydroxyethylcellulose, Polysorbate 20, Disodium Stearoyl Glutamate, Ceramide Np, Caprylyl Glycol, Maltodextrin, Acetyl Dipeptide-1 Cetyl Ester, Palmitoyl Tripeptide-5, Palmitoyl Pentapeptide-4

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: The firming watery cream makes skin elastic and moisturized with ingredients such as glacial water from the perennial snow of pristine Iceland and Alpen Rose (Rhododendron Ferrugineum Extract) that grows strong under the harsh environment of the Alps.

Directions

Directions: At the last step of skin care, apply an appropriate amount on the entire face and gently pat to promote absorption into skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICELAND FIRMING WATERY CREA M 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-485
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.08 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-485-02	1 in 1 CARTON	06/01/2017	11/01/2019
1	NDC: 51346-485-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2017	11/01/2019

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-485)

Revised: 1/2020

Document Id: 3f9fdd23-5844-470f-b21e-e7b93a8623e0

34390-5

Set id: e7a14015-fbaa-420d-ac4f-26c7eb23b763

Version: 2

Effective Time: 20200114

 

NATURE REPUBLIC CO., LTD.