SKEDERM ULTIMATE EYE- niacinamide cream 
Skederm Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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70209-001_Deactivation

Niacinamide 2.00%

Skin Protectant

An eye treatment that moisturizes and helps minimize the look of dark circles, shadows, and puffiness

Apply liberally as needed onto skin

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Isohexadecane, Glycerin, Triethylhexanoin, Sorbitan Stearate, Stearic Acid, Butylene Glycol, Cetyl Alcohol, Sorbitan Oleate, Dioscorea Japonica Root Extract, Phellinus Linteus Extract, Arctium Lappa Root Extract, Piper Methysticum Leaf/Root/Stem Extract, Portulaca Oleracea Extract, Pueraria Thunbergiana Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Lactiflora Root Extract, Cnidium Officinale Root Extract, Pseudoalteromonas Ferment Extract, Salvia Hispanica Seed Extract, Citrus Aurantium Dulcis (Orange) Oil, Soluble Collagen, Hydrogenated Lecithin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Sodium Hyaluronate, Litsea Cubeba Fruit Oil, Dimethicone, 1,2-Hexanediol, Polysorbate 60, Sucrose Cocoate, Tromethamine, Squalane, Hydrogenated Polyisobutene, Ethylhexylglycerin, Alcohol, Carbomer, Polyquaternium-51, Glycosyl Trehalose, Glyceryl Polymethacrylate, Isononyl Isononanoate, Polyglyceryl-10 Stearate, Hydrogenated Starch Hydrolysate, Raffinose, Disodium EDTA, Biosaccharide Gum-1, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Dipolyhydroxystearate, Lecithin, Panthenol, Inulin Lauryl Carbamate, Xanthan Gum, Folic Acid, Disodium Stearoyl Glutamate, Hydrolyzed Hyaluronic Acid, Ceramide Np, Cholesterol, Caprylyl Glycol, Retinol, Palmitoyl Pentapeptide-4, Phenoxyethanol

image description

SKEDERM ULTIMATE EYE 
niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70209-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)  
PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)  
PURSLANE (UNII: M6S840WXG5)  
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
CHIA SEED (UNII: NU0OLX06F8)  
ORANGE OIL (UNII: AKN3KSD11B)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGAN OIL (UNII: 4V59G5UW9X)  
MANDARIN OIL (UNII: NJO720F72R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LITSEA OIL (UNII: 2XIW34BN6O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SQUALANE (UNII: GW89575KF9)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
RAFFINOSE (UNII: N5O3QU595M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FOLIC ACID (UNII: 935E97BOY8)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
CERAMIDE NP (UNII: 4370DF050B)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
RETINOL (UNII: G2SH0XKK91)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ADENOSINE (UNII: K72T3FS567)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70209-001-021 in 1 PACKAGE01/26/201801/28/2020
1NDC:70209-001-0115 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/201801/28/2020
Labeler - Skederm Inc. (079981781)
Registrant - Skederm Inc. (079981781)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(70209-001)

Revised: 1/2020
 
Skederm Inc.