SKEDERM SMART NECK- dimethicone cream 
Skederm Inc.

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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70209-005_Deactivation

Dimethicone 2.08%

Skin Protectant

Firming, hydrating, and improving the appearance of neck
lines, and crepiness

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, Glycerin, Hydrogenated Poly(C6-14 Olefin), Caprylic/Capric Triglyceride, Polyglyceryl-3 Methylglucose Distearate, Niacinamide, Glyceryl Stearate, Cetyl Alcohol, Dioscorea Japonica Root Extract, Dimethiconol, Methylpropanediol, Cyclopentasiloxane, 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, Euterpe Oleracea Fruit Extract, Lepidium Meyenii Root Extract, Soluble Collagen, Citrus Aurantium Dulcis (Orange) Oil, Macadamia Ternifolia Seed Oil, Aloe Barbadensis Leaf Juice, Hydrogenated Lecithin, Argania Spinosa Kernel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Rosa Canina Fruit Oil, Litsea Cubeba Fruit Oil, Sodium Hyaluronate, 1,2-Hexanediol, Polysorbate 20, PEG-100 Stearate, Polyacrylate-13, Polyisobutene, Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Polyquaternium-51, Glycosyl Trehalose, Tromethamine, Squalane, Hydrogenated Polyisobutene, Butylene Glycol, Sodium Stearoyl Glutamate, Alcohol, Hydrogenated Starch Hydrolysate, Raffinose, Biosaccharide Gum-1, Adenosine, Isononyl Isononanoate, Polyglyceryl-10 Stearate, Lecithin, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Stearic Acid, Polyglyceryl-2 Dipolyhydroxystearate, Madecassoside, Panthenol, Xanthan Gum, VP/Polycarbamyl Polyglycol Ester, Sorbitan Laurate, Hydrolyzed Sesame Protein PG-Propyl Methylsilanediol, Inulin Lauryl Carbamate, Folic Acid, Hydroxyethylcellulose, Ceramide NP, Cholesterol, Acetyl Dipeptide-1 Cetyl Ester, Disodium Stearoyl Glutamate, Caprylyl Glycol, Maltodextrin, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Phenoxyethanol

image description

SKEDERM SMART NECK 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70209-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.04 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
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)  
ACAI (UNII: 46AM2VJ0AW)  
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)  
ORANGE OIL (UNII: AKN3KSD11B)  
MACADAMIA OIL (UNII: 515610SU8C)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ARGAN OIL (UNII: 4V59G5UW9X)  
MANDARIN OIL (UNII: NJO720F72R)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
LITSEA OIL (UNII: 2XIW34BN6O)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SQUALANE (UNII: GW89575KF9)  
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
RAFFINOSE (UNII: N5O3QU595M)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
ADENOSINE (UNII: K72T3FS567)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
FOLIC ACID (UNII: 935E97BOY8)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
CERAMIDE NP (UNII: 4370DF050B)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70209-005-021 in 1 CARTON06/29/201701/28/2020
1NDC:70209-005-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/29/201701/28/2020
Labeler - Skederm Inc. (079981781)
Registrant - Skederm Inc. (079981781)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(70209-005)

Revised: 1/2020
 
Skederm Inc.