28 REMEDY BALANCING TONER 100ML- 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 Ingredient: Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract 1.0%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Methyl Gluceth-20, Alcohol, Niacinamide, Butylene Glycol, Beta-Glucan, Betaine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Methyl paraben, Allantoin, Chlorphenesin, Colloidal Sulfur, Melia Azadirachta Extract, Opuntia Ficus-Indica Callus Culture Extract, Human Oligopeptide-1, Aloe Barbadensis Leaf Juice, Rosa Centifolia Flower Extract, Centella Asiatica 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, Salicylic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Propylene Glycol

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

Stop use and ask dermatologist or doctor if

•signs of redness, skin swelling, itchy spots, irritation or rash and other appear

•the above signs appear in the applied area by direct rays of the sun

Do not use over

•wounds rashes inflammations other troubled areas.

When using

•Avoid the eye area

•must close the cap after using

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses:

Skin Soothing and calming

Directions

Directions

•Wash your face and dry

•Dispense appropriate amount on your hand

•Apply over your face using your fingers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY BALANCING TONER 100ML 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel1.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Methyl Gluceth-20 (UNII: J3QD0LD11P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-100-01100 mL in 1 CARTON; Type 0: Not a Combination Product01/02/201612/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/201612/01/2018
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(69716-100)

Revised: 12/2018
 
NoTS Co.,Ltd