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

P1P AC Repair Ampoule by

Drug Labeling and Warnings

P1P AC Repair Ampoule by is a Otc medication manufactured, distributed, or labeled by Phytos Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WarningsFor external use onlyDo not use when Your skin is red, inflamed, irritated or painfulWhen 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 

DirectionsApply 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

INGREDIENTS AND APPEARANCE

P1P AC REPAIR AMPOULE 
niacinamide, salicylic acid,phytosphingosine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69579-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.02   in 30 mL
Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic acid	0.003   in 30 mL
Phytosphingosine (UNII: GIN46U9Q2Q) (Phytosphingosine - UNII:GIN46U9Q2Q)	Phytosphingosine	0.001   in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69579-108-02	1 in 1 BOX
1	NDC: 69579-108-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/07/2016

Labeler - Phytos Co., Ltd. (689196775)

Registrant - Phytos Co., Ltd. (689196775)

Establishment
Name	Address	ID/FEI	Business Operations
Phytos Co., Ltd.		689196775	manufacture(69579-108)