NDC Code(s) : 63181-0016-1
Packager : Sesvalia USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SALISES FACIAL Moisturizing acne treatment gelSALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63181-0016
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
NIACINAMIDE(UNII: 25X51I8RD4)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
AMMONIUM GLYCYRRHIZATE(UNII: 3VRD35U26C)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
PANTHENOL(UNII: WV9CM0O67Z)
BOSWELLIA SERRATA WHOLE(UNII: X7B7P649WQ)
CAFFEINE(UNII: 3G6A5W338E)
BIOTIN(UNII: 6SO6U10H04)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
ACETYL DIPEPTIDE-1 CETYL ESTER(UNII: 3M7W78X5IR)
TRIDECETH-9(UNII: X9HD79I514)
EDETATE DISODIUM(UNII: 7FLD91C86K)
YEAST(UNII: 3NY3SM6B8U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
LAURETH-3(UNII: F32E4CB0UJ)
SODIUM CHOLATE(UNII: NU3Y4CCH8Z)
POLYSORBATE 20(UNII: 7T1F30V5YH)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
LINALOOL, (+)-(UNII: F4VNO44C09)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Product Characteristics
Color WHITE (Viscous hazy colorless to off-white liquid) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63181-0016-11 in 1 BOX
150 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 04/04/2014

PRINCIPAL DISPLAY PANEL

SALISES

FACIAL

 Moisturizing acne

 treatment gel

1.5 % Salicylic acid

1.7 fl oz ( 50 ml )

sesderma

Manufactured by:

SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain)

Customer service: 902 100 223.

Distributed by:

SESVALIA USA LLC.

67 Miracle Mile, Coral Gables, FL 33134 USA. USA

Customer service: (1) 800 796 0996.

www.sesderma.com

Made in SPAIN

SALISESFacialOuter