NDC Code(s) : 70017-001-01
Packager : CLASSYS INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cluederm Aqua Solution Sebo PlusSalicylic Acid LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70017-001
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 ACID2.5 mg in 500 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
LACTIC ACID(UNII: 33X04XA5AT)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HONEY(UNII: Y9H1V576FH)
FILIPENDULA ULMARIA WHOLE(UNII: 3LH0M209LN)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ZINC PIDOLATE(UNII: C32PQ86DH4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
AZADIRACHTA INDICA LEAF(UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER(UNII: 3TE8A92UPM)
TURMERIC(UNII: 856YO1Z64F)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CORALLINA OFFICINALIS(UNII: 4004498D06)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70017-001-01150 mL in 1 CONTAINER Type 0: Not a Combination Product28/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/28/2018

PRINCIPAL DISPLAY PANEL

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