LYCORIS RUBUS WHITENING FLUID- allantoin cream 
Lycoris 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: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Alcohol Denat., Glycerin, Arbutin, Sodium Hyaluronate, Rubus Hirsutus Fruit/Leaf Extract(1%), Betaine, PEG/PPG-17/6 Copolymer, Phenoxyethanol, PEG-60 Hydrogenated Castor Oil, Bis-PEG-18MethylEtherDimethylSilane, Trehalose, Methylparaben, Carbomer, Allantoin, Camellia Japonica Ovary Powder, Potassium Hydroxide, Xanthan Gum, Glyceryl Acrylate/Acrylic Acid Copolymer, Sodium Metabisulfite, Disodium EDTA, Caramel, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Propylene Glycol

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problem such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In the case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

DOSAGE AND ADMINISTRATION

Dosage and administration: Apply after washing face. Take a small amount of fluid about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

LYCORIS RUBUS WHITENING FLUID 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60778-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.67 mg  in 135 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60778-040-01135 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2013
Labeler - Lycoris Co., Ltd. (688301521)
Registrant - Lycoris Co., Ltd. (688301521)
Establishment
NameAddressID/FEIBusiness Operations
Lycoris Co., Ltd.688301521manufacture(60778-040)

Revised: 10/2013
Document Id: 7b76a3f7-baa7-456b-9236-46ff4a385473
Set id: 835b4c6b-3c39-4d51-81a9-29796405dafa
Version: 1
Effective Time: 20131008
 
Lycoris Co., Ltd.