KIKO MILANO SHINE REFINE SPOT- salicylic acid cream
KIKO USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KIKO MILANO SHINE REFINE SPOT

Drug Facts

Active ingredient

Salicylic acid 1%

Purpose

Acne treatment

Uses

for the treatment of acne
clears acne blemishes and allows skin to heal
penetrates pores to eliminate most blackheads
helps keep skin clear of new acne pimples

Warnings

For external use only.

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

WATER, SD ALCOHOL 40-B, BUTYLENE GLYCOL, PROPANEDIOL, HAMAMELIS VIRGINIANA (WITCH HAZEL) FLOWER WATER, POLYACRYLATE CROSSPOLYMER-6, PHENOXYETHANOL, HYDROXYETHYLCELLULOSE, ALLANTOIN, ETHYLENE BRASSYLATE, ETHYLHEXYLGLYCERIN, SODIUM HYDROXIDE, LENS ESCULENTA (LENTIL) SEED EXTRACT, DISODIUM EDTA, t-BUTYL ALCOHOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, BENZYL ALCOHOL, DEHYDROACETIC ACID.

Questions or comments?

Call +1 (646) 435-5586

DISTRIBUTED BY KIKO USA, Inc.
470 PARK AVENUE SOUTH
NEW YORK, NY 10016

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton

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

KIKO MILANO SHINE REFINE SPOT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69049-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.15105 g in 15 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69049-019-01	1 in 1 CARTON	12/20/2016	03/01/2019
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/20/2016	03/01/2019

Labeler - KIKO USA, Inc. (079329016)

Revised: 12/2018

Document Id: 7e0be5db-faf8-423c-99a8-2054ee9c2beb

Set id: 47b11319-3308-4fb7-9c88-34cbaf3b93ff

Version: 2

Effective Time: 20181203

KIKO USA, Inc.