P1P MELA CARE- niacinamide, panthenol liquid

P1P Mela Care by

Drug Labeling and Warnings

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

Drug Details [pdf]

P1P Mela Care

Niacinamide (2.5%)Panthenol (1%) 

skin protectant

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

Skin brightening care

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 moderate amount gently on face

Water, Tranexamic Acid, Cetyl Ethylhexanoate, Urea, Glycolic acid, 3-O-Ethyl Ascorbic Acid, Bacillus/Soybean Ferment Extract, 1,2-Hexanediol, Lecithin, Glycerin, Sodium Hyaluronate, Glycosyl Trehalose, Polysorbate 80, Poloxamer 407, Bisabolol, Dipotassium Glycyrrhixate, Phytosphigosine Phosphate

INGREDIENTS AND APPEARANCE

P1P MELA CARE 
niacinamide, panthenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69579-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.025   in 30 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.01   in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
UREA (UNII: 8W8T17847W)
GLYCOLIC ACID (UNII: 0WT12SX38S)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLOXAMER 407 (UNII: TUF2IVW3M2)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69579-101-02	1 in 1 CARTON
1	NDC: 69579-101-01	30 mL in 1 AMPULE

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	Business Operations
Phytos Co., Ltd.		689196775	manufacture(69579-101)