NDC Code(s) : 58414-8321-1
Packager : NeoStrata Company Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NeoStrata Antibacterial Facial CleanserTRICLOSAN LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58414-8321
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN(UNII: 4NM5039Y5X)
(TRICLOSAN - UNII:4NM5039Y5X) 		TRICLOSAN3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
AMMONIUM CHLORIDE(UNII: 01Q9PC255D)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
GLYCINE(UNII: TE7660XO1C)
LAURYL ALCOHOL(UNII: 178A96NLP2)
METHYLPARABEN(UNII: A2I8C7HI9T)
PANTHENOL(UNII: WV9CM0O67Z)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
TROLAMINE(UNII: 9O3K93S3TK)
SULFATE ION(UNII: 7IS9N8KPMG)
CHAMOMILE(UNII: FGL3685T2X)
POLYQUATERNIUM-10 (400 MPA.S AT 2%)(UNII: HB1401PQFS)
DISODIUM COCOAMPHODIACETATE(UNII: 18L9G3U51M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58414-8321-11 in 1 CARTON
1177 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 NOT FINAL part333E 04/25/2011 11/12/2018

PRINCIPAL DISPLAY PANEL

NeoStrata ®

REFINE

Antiaging for oily and
blemish prone skin

Antibacterial
Facial
Cleanser

4 PHA

6.0 fl oz / 177 ml e

Principal Display Panel - 177ml Carton