28 Remedy Eye Repair Concentrate by NoTS Co Ltd

Drug Details [pdf]

28 REMEDY EYE REPAIR CONCENTRATE- witch hazel cream
NoTS 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: Witch Hazel 0.0001%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Mineral Oil, Glycerin, Hydrogenated Polyisobutene, Butylene Glycol Dicaprylate/Dicaprate, Cetearyl Alcohol, Limnanthes Alba (Meadowfoam) Seed Oil, Butylene Glycol, Cyclomethicone, Polyglyceryl-3 Methylglucose Distearate, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Niacinamide, Diisostearyl Malate, Glyceryl Stearate SE, Sodium Hyaluronate, Paraffin, Dimethicone, Tocopheryl Acetate, Beeswax, Methylparaben, Triethanolamine, Carbomer, Glyceryl Stearate, PEG-100 Stearate, Propylparaben, Opuntia Ficus-Indica Callus Culture Extract, Human Oligopeptide-1, Rosa Centifolia Flower Water, Centella Asiatica Extract, Arnica Montana Flower Extract, Anthemis Nobilis Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Brassica Oleracea Italica (Broccoli) Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Allium Sativum (Garlic) Bulb Extract, Camellia Sinensis Leaf Extract, Juglans Regia (Walnut) Seed Extract, Spinacia Oleracea (Spinach) Leaf Extract, Avena Sativa (Oat) Meal Extract, Vitis Vinifera (Grape) Fruit Extract, Salicornia Herbacea Extract, Adenosine, Xanthan Gum, Disodium EDTA

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. Discontinue use if the following abnormal situations occur. If you continue to use, it may worsen symptoms, consult a dermatologist etc. A) If signs of redness, skin swelling, itchy spots, irritation or rash etc appear B) If the above signs appear in the applied area by direct rays of the sun. 2. Do not use over wounds, rashes, inflammations or other troubled areas. 3. Notice when maintaining and handling A) You must close the cap after using B) Do not keep in the place of high or low temperature and in direct sunlight

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indications & Usage: After using 28 REMEDY Intensive Serum, dispense an appropriate amount on your palm and use your fingers to massage along the skin texture of eye rim.

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY EYE REPAIR CONCENTRATE
witch hazel cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69716-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	Witch Hazel	0.00001 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Mineral Oil (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69716-050-01	15 g in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/01/2015	12/01/2018

Labeler - NoTS Co Ltd (689004599)

Registrant - NoTS Co Ltd (689004599)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(69716-050)

Revised: 12/2019

Document Id: b42efdd9-5b78-4fe1-941f-10b20537c9f6

Set id: 48165306-da1a-44ce-818f-00f78cefe072

Version: 2

Effective Time: 20191203

NoTS Co Ltd