P1P SKIN REBIRTH CREAM- dimethicone, adenosine cream 
Phytos Co., Ltd.

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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P1P Skin Rebirth Cream

P1P Skin Rebirth Cream

skin birth cream

Dimethicone (1%)
Adenosine (0.4%) 

skin protectant

Keep out of reach of children
- Do not swallow. In case of accidental ingestion, seek professional assistance.

Moisturizes Skin

Warnings
For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product
- Do not apply on other parts of the body
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Do not apply directly to wound or open cut.
Stop use and ask doctor if rash or irritation on skin develops and lasts.
Store at room temperature 

Apply moderate amount gently on face

Water, Glycerin, Caprylic/Capric Triglyceride, Butylene Glycol, Tremella Fuciformis (Mushroom) Extract, Glyceryl Polyacrylate, Sodium Hyaluronate (1%), Centella Asiatica Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Cetyl Ethylhexanoate, Lactoglobulin, Sodium Dehydroacetate, Cetearyl Alcohol, Glyceryl Stearate, Phytosteryl/Decyltetradecyl Myristoyl Methyl Beta-Alaninate, Stearic Acid, Tocopheryl Acetate, Totarol, Batyl Alcohol, Lecithin, Arginine, Ethyl Ascorbyl Ether, Carbomer, Phytosphingosine Phosphate, Poloxamer 407, Polysorbate80, 1,2-Hexanediol, Isododecane, Vinyl Dimethicone/Lauryl Dimethicone
Crosspolymer, Lauryl Dimethicone, Citrus Paradisi (Grapefruit)Seed Extract, Artemisia Vulgaris Extract, Octanediol, Ethylhexylglycerin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polysorbate20, Sodium Ascorbyl Phosphate, Bacillus/Soybean/Folic Acid Ferment Extract, Acetyl Glutamine, rh-Oligopeptide-1, rh-Oligopeptide-2, rh-Polypeptide-1, rh-Polypeptide-11, rh-Polypeptide-9, Disodium EDTA

P1P SKIN REBIRTH CREAM 
dimethicone, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69579-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) dimethicone0.01   in 30 mL
adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) adenosine0.004   in 30 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
cetyl ethylhexanoate (UNII: 134647WMX4)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
stearic acid (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
totarol (UNII: 67NH2854WW)  
BATILOL (UNII: 39YR661C4U)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ARGININE (UNII: 94ZLA3W45F)  
poloxamer 407 (UNII: TUF2IVW3M2)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
isododecane (UNII: A8289P68Y2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
LAURYL TRISILOXANE (UNII: 5OHO78HI1D)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
octanediol (UNII: 806K32R50Z)  
ethylhexylglycerin (UNII: 147D247K3P)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
polysorbate 20 (UNII: 7T1F30V5YH)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ACEGLUTAMIDE (UNII: 01J18G9G97)  
NEPIDERMIN (UNII: TZK30RF92W)  
MECASERMIN (UNII: 7GR9I2683O)  
BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)  
FIBROBLAST GROWTH FACTOR-1 (UNII: G53298VN9Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69579-103-021 in 1 CARTON
1NDC:69579-103-0130 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/2015
Labeler - Phytos Co., Ltd. (689196775)
Registrant - Phytos Co., Ltd. (689196775)
Establishment
NameAddressID/FEIBusiness Operations
Phytos Co., Ltd.689196775manufacture(69579-103)

Revised: 1/2015
Document Id: 42a365db-1d93-435c-b585-41a0783a8e31
Set id: d815532b-8e76-4db9-8086-ac055501af90
Version: 1
Effective Time: 20150126
 
Phytos Co., Ltd.