28 Remedy Repair by NoTS Co Ltd

Drug Details [pdf]

28 REMEDY REPAIR- dimethicone 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: Dimethicone 1.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Melia Azadirachta Extract, Glycerin, Stearyl Alcohol, Beeswax, Niacinamide, Ceresin, Hydrogenated Polyisobutene, Hyaluronic Acid, Beta-Glucan, Glyceryl Stearate, PEG-100 Stearate, Betaine, Polysorbate 60, Cetyl Ethylhexanoate, Emu Oil, Colloidal Sulfur, 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, Opuntia Ficus-Indica Callus Culture 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, Rosa Centifolia Flower Water, Anthemis Nobilis Flower Extract, Centella Asiatica Extract, Arnica Montana Flower Extract, Sorbitan Stearate, Cetearyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sophora Angustifolia Root Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Butyrospermum Parkii (Shea Butter), Zeolite, Hydroxyapatite, Zirconium Silicate, Silver, Zinc Oxide, Triethanolamine, Cetearyl Glucoside, Tocopheryl Acetate, Carbomer, Methylparaben, Propagermanium, Human Oligopeptide-1, Retinyl Palmitate, PEG-40 Hydrogenated Castor Oil, Butylparaben, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, BHT, Adenosine, Propylene Glycol, Butylene Glycol, Phenoxyethanol

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 (or Eye Repair Concentrate), dispense an appropriate amount on your palm and use fingers to gently spread on your face and neck along the skin texture.

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY REPAIR
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69716-060
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.3 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
MELIA AZEDARACH WHOLE (UNII: 18X4G0SE73)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69716-060-01	30 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
Nowcos.Co.,Ltd		689914984	manufacture(69716-060)

Revised: 12/2019

Document Id: 55cc0190-eca0-4c99-9495-81248989922d

Set id: 7410d895-1f3b-4401-b989-bf220caf4307

Version: 2

Effective Time: 20191203