SHISEIDO IBUKI MULTI- salicylic acid gel

SHISEIDO IBUKI MULTI by

Drug Labeling and Warnings

SHISEIDO IBUKI MULTI by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

SALICYLIC ACID 0.5%

Purpose

Acne treatment

Use

• for the treatment of acne

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.
• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. If product is 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

WATERBUTYLENE GLYCOLSD ALCOHOL 40-BDIMETHICONEPEG/PPG-14/7 DIMETHYL ETHERPEG-240/HDI COPOLYMER BIS-DECYLTETRADECETH-20 ETHERGLYCYL GLYCINEPEG-60 HYDROGENATED CASTOR OILSILICATREHALOSESODIUM CHLORIDEGELLAN GUMDIPOTASSIUM GLYCYRRHIZATESERINEPOLYQUATERNIUM-51PAEONIA SUFFRUTICOSA ROOT EXTRACTAESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACTHYDROGENATED LECITHINPOTASSIUM HYDROXIDEDISODIUM EDTASODIUM CITRATEACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMERALCOHOLCITRIC ACIDGLYCERINBHTPEG-30 SOY STEROLTRISODIUM EDTAPHENOXYETHANOLFRAGRANCEYELLOW 5BLUE 1

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton

SHI SEIDO

Total Skin Rescue

IBUKI

Multi Solution Gel

roughness + visible pore care
+ salicylic acid acne treatment

30mL NET WT. 1 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO IBUKI MULTI 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	154 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIGLYCINE (UNII: 10525P22U0)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SERINE (UNII: 452VLY9402)
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE TRISODIUM (UNII: 420IP921MB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-340-50	1 in 1 CARTON	02/01/2015
1		30 mL in 1 JAR; 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	02/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-340) , analysis(58411-340)