P1P MELA CARE- niacinamide, panthenol 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 Mela Care

P1P Mela Care

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

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 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

P1P MELA CARE
niacinamide, panthenol liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/26/2015

Labeler - Phytos Co., Ltd. (689196775)

Registrant - Phytos Co., Ltd. (689196775)

Name	Address	ID/FEI	Business Operations
Establishment
Phytos Co., Ltd.		689196775	manufacture(69579-101)

Revised: 1/2015

Document Id: caf0d216-4795-4328-852b-f1a047a6b293

Set id: 56c6d83e-9ea6-45b4-9e7e-78fb852823a6

Version: 2

Effective Time: 20150128

Phytos Co., Ltd.