OTC Medication Information: P1P Skin Rebirth Cream

P1P SKIN REBIRTH CREAM- dimethicone and 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.

P1P Skin Rebirth Cream

skin birth cream
(click image for full-size original)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:69579-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dimethicone (DIMETHICONE) dimethicone 0.01 in 30 mL
adenosine (ADENOSINE) adenosine 0.004 in 30 mL
Inactive Ingredients
Ingredient Name Strength
water
glycerin
MEDIUM-CHAIN TRIGLYCERIDES
BUTYLENE GLYCOL
TREMELLA FUCIFORMIS WHOLE
HYALURONATE SODIUM
CENTELLA ASIATICA
MEADOWFOAM SEED OIL
PALMITOYL OLIGOPEPTIDE
PALMITOYL TETRAPEPTIDE-7
cetyl ethylhexanoate
SODIUM DEHYDROACETATE
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
stearic acid
.ALPHA.-TOCOPHEROL ACETATE
totarol
BATILOL
EGG PHOSPHOLIPIDS
ARGININE
poloxamer 407
polysorbate 80
1,2-HEXANEDIOL
isododecane
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)
LAURYL TRISILOXANE
CITRUS PARADISI SEED
ARTEMISIA VULGARIS ROOT
octanediol
ethylhexylglycerin
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
polysorbate 20
SODIUM ASCORBYL PHOSPHATE
ACEGLUTAMIDE
NEPIDERMIN
MECASERMIN
BASIC FIBROBLAST GROWTH FACTOR (HUMAN)
FIBROBLAST GROWTH FACTOR-1
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69579-103-02 1 CONTAINER in 1 CARTON contains a CONTAINER (69579-103-01)
1 NDC:69579-103-01 30 mL in 1 CONTAINER This package is contained within the CARTON (69579-103-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/26/2015
Labeler — Phytos Co., Ltd. (689196775)
Registrant — Phytos Co., Ltd. (689196775)
Establishment
Name Address ID/FEI Operations
Phytos Co., Ltd. 689196775 manufacture (69579-103)

Revised: 01/2015 Phytos Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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