P1P AC REPAIR AMPOULE- niacinamide, salicylic acid,phytosphingosine liquid 
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 AC Repair Ampoule

Niacinamide (2%)
Salicylic acid (0.3%) 
Phytosphingosine (0.1%) 

Skin Protectant

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

Moisturizes skin. Keep skin soft and smooth and helps to improve sensitive skin elasticity.

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 

Directions
Apply 1-2 drops on over the face after cleansing the face. After applying the applicator, use sunscreen in the morning.

Water, Cetyl Ethylhexanoate, Aspalathus Linearis Extract, Totarol, Dimethyl sulfone, Glycerin, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Glycolic acid, 1,2-Hexanediol, Tranexamic Acid, Lecithin, Polysorbate 80, Tocopheryl Acetate, Poloxamer 407, Dipotassium Glycyrrhizate, Phytosphingosine Phosphate

P1P AC Repair Ampoule

p1p ac repair

P1P AC REPAIR AMPOULE 
niacinamide, salicylic acid,phytosphingosine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69579-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 30 mL
Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic acid0.003   in 30 mL
Phytosphingosine (UNII: GIN46U9Q2Q) (Phytosphingosine - UNII:GIN46U9Q2Q) Phytosphingosine0.001   in 30 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Cetyl Ethylhexanoate (UNII: 134647WMX4)  
Totarol (UNII: 67NH2854WW)  
Dimethyl sulfone (UNII: 9H4PO4Z4FT)  
Glycerin (UNII: PDC6A3C0OX)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
Glycolic acid (UNII: 0WT12SX38S)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Tranexamic Acid (UNII: 6T84R30KC1)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69579-108-021 in 1 BOX
1NDC:69579-108-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/07/2016
Labeler - Phytos Co., Ltd. (689196775)
Registrant - Phytos Co., Ltd. (689196775)
Establishment
NameAddressID/FEIBusiness Operations
Phytos Co., Ltd.689196775manufacture(69579-108)

Revised: 1/2016
Document Id: 140fe2da-993e-4805-a43a-4945459cdd0d
Set id: 44706353-2f38-496e-a0dd-b9995ad1f05a
Version: 1
Effective Time: 20160107
 
Phytos Co., Ltd.