28 Remedy Balancing Toner by NoTS Co Ltd

28 Remedy Balancing Toner by

Drug Labeling and Warnings

28 Remedy Balancing Toner by is a Otc medication manufactured, distributed, or labeled by NoTS Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

28 REMEDY BALANCING TONER- 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: Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract 1.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Methyl Gluceth-20, Alcohol, Niacinamide, Beta-Glucan, Butylene Glycol, Betaine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Methylparaben, Allantoin, Chlorphenesin, Colloidal Sulfur, Melia Azadirachta Extract, Opuntia Ficus-Indica Callus Culture Extract, Human Oligopeptide-1, Aloe Barbadensis Leaf Juice, 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, Citrus Paradisi (Grapefruit) Fruit Extract, Sophora Angustifolia Root Extract, Adenosine, Disodium EDTA, Melaleuca Alternifolia (Tea Tree) Leaf Oil

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 washing face, dispense an appropriate amount on your palm and use fingers to gently spread on your face and neck.

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28 REMEDY BALANCING TONER 
witch hazel cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69716-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	Witch Hazel	1.0 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69716-030-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	12/01/2018

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

Labeler - NoTS Co Ltd (689004599)

Registrant - NoTS Co Ltd (689004599)

Establishment
Name	Address	ID/FEI	Business Operations
Nowcos.Co.,Ltd		689914984	manufacture(69716-030)

Revised: 12/2019

Document Id: d91d9da5-70ab-449d-8dca-16c692a54ab9

34390-5

Set id: 0df8f438-b52e-4ded-ac4f-c6fe71391a99

Version: 2

Effective Time: 20191203

 

NoTS Co Ltd