NDC Code(s) : 69049-019-01
Packager : KIKO USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KIKO MILANO SHINE REFINE SPOTSALICYLIC ACID CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69049-019
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 ACID0.15105 g in 15 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPANEDIOL(UNII: 5965N8W85T)
HAMAMELIS VIRGINIANA FLOWER WATER(UNII: 222MYC9QUV)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
ALLANTOIN(UNII: 344S277G0Z)
ETHYLENE BRASSYLATE(UNII: 9A87HC7ROD)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
LENTIL(UNII: 6O38V6B52O)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
TERT-BUTYL ALCOHOL(UNII: MD83SFE959)
TEA TREE OIL(UNII: VIF565UC2G)
BENZYL ALCOHOL(UNII: LKG8494WBH)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69049-019-011 in 1 CARTON 20/12/2016
115 mL in 1 TUBE 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 12/20/2016

PRINCIPAL DISPLAY PANEL

SHINE
REFINE
SPOT

SALICYLIC ACID
ACNE TREATMENT

COMBINATION TO OILY SKIN

FACE

KIKO
MILANO

e 15 ml / 0.50 FL.OZ.

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton