NDC Code(s) : 16047-0028-1
Packager : Sesderma USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SALISES FACIAL Moisturizing Acne Treatment Gel 50mlSALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16047-0028
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
ACETYL DIPEPTIDE-1 CETYL ESTER(UNII: 3M7W78X5IR)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
AMMONIUM GLYCYRRHIZATE(UNII: 3VRD35U26C)
BIOTIN(UNII: 6SO6U10H04)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
CAFFEINE(UNII: 3G6A5W338E)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
EDETATE DISODIUM(UNII: 7FLD91C86K)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
ETHYLPARABEN(UNII: 14255EXE39)
LAURETH-3(UNII: F32E4CB0UJ)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
METHYLPARABEN(UNII: A2I8C7HI9T)
NIACINAMIDE(UNII: 25X51I8RD4)
PANTHENOL(UNII: WV9CM0O67Z)
PEG/PPG-20/6 DIMETHICONE(UNII: PWZ7N4UIKE)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYSORBATE 20(UNII: 7T1F30V5YH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM CHOLATE(UNII: NU3Y4CCH8Z)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
TRIDECETH-9(UNII: X9HD79I514)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
WATER(UNII: 059QF0KO0R)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
ZINC PIDOLATE(UNII: C32PQ86DH4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16047-0028-11 in 1 CARTON
150 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
OTC monograph final part333D 06/16/2015

PRINCIPAL DISPLAY PANEL

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