SKEDERM VITAMIN C X30 POWER SERUM by Skederm Inc. / Kolmar Korea Co., Ltd. 70209-003_Deactivation

SKEDERM VITAMIN C X30 POWER SERUM by

Drug Labeling and Warnings

SKEDERM VITAMIN C X30 POWER SERUM by is a Otc medication manufactured, distributed, or labeled by Skederm Inc., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKEDERM VITAMIN C X30 POWER SERUM- dimethicone 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.

----------

70209-003_Deactivation

GLYCERIN 4.44%

Skin Protectant

To provide hydration and promote attractiveness to skin

Apply gently over clean, dry skin or/and desired area 1 to 2 times daily
For morning and evening use

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, Triethylhexanoin, Hydrogenated Poly(C6-14 Olefin), Cetyl Alcohol, Methylpropanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-100 Hydrogenated Castor Oil, Hydrogenated Lecithin, 3-O-Ethyl Ascorbic Acid, Behenyl Alcohol, Betaine, Polyglyceryl-10 Myristate, Piper Methysticum Leaf/Root/Stem Extract, Aloe Barbadensis Leaf Juice, 1,2-Hexanediol, Arctium Lappa Root Extract, Phellinus Linteus Extract, Soluble Collagen, Phenoxyethanol, Xanthan Gum, Dioscorea Japonica Root Extract, Citric Acid, Sodium Citrate, C12-14 Pareth-7, Portulaca Oleracea Extract, Pueraria Thunbergiana Root Extract, Cnidium Officinale Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Lactiflora Root Extract, Squalane, Ethylhexylglycerin, Fragrance, Tocopheryl Acetate, Trisodium EDTA, Polysorbate 60, Polyquaternium-51, Glycosyl trehalose, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Starch Hydrolysate, Biosaccharide Gum-1, PVM/MA Copolymer, Raffinose, Sodium Polyacrylate, Lecithin

SKEDERM VITAMIN C X30 POWER SERUM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70209-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.33 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
DOCOSANOL (UNII: 9G1OE216XY)
BETAINE (UNII: 3SCV180C9W)
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
C12-14 PARETH-7 (UNII: R66I1M1LNH)
PURSLANE (UNII: M6S840WXG5)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BEMISIOSE (UNII: 76B4LOB2YC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
RAFFINOSE (UNII: N5O3QU595M)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70209-003-02	1 in 1 PACKAGE	01/26/2018	01/28/2020
1	NDC: 70209-003-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/26/2018	01/28/2020

Labeler - Skederm Inc. (079981781)

Registrant - Skederm Inc. (079981781)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(70209-003)

Revised: 1/2020

Document Id: 9d3bcb94-c863-b8fe-e053-2995a90a87a5

34390-5

Set id: 151fc6b1-1955-4499-93cc-95594dd43f4c

Version: 4

Effective Time: 20200128

 

Skederm Inc.