Drug Facts

Active ingredients

SALICYLIC ACID 0.5%

Purpose

Acne medication

Uses

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.

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▪BUTYLENE GLYCOL▪DIPROPYLENE GLYCOL▪DIMETHICONE▪PEG-6▪PEG-32▪PEG-240/HDI COPOLYMER BIS-DECYLTETRADECETH-20 ETHER▪ERYTHRITOL▪GLYCERIN▪PEG/PPG-14/7 DIMETHYL ETHER▪DIPOTASSIUM GLYCYRRHIZATE▪PAEONIA ALBIFLORA ROOT EXTRACT▪HYDROLYZED RICE EXTRACT▪CITRUS DEPRESSA PEEL EXTRACT▪ISOSTEARYL ALCOHOL▪CARBOMER▪POTASSIUM HYDROXIDE▪SODIUM METAPHOSPHATE▪ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER▪BHT▪PHENOXYETHANOL▪BENZOIC ACID▪ <M095042-811>

Other information

cap contains natural materials that may change color/texture over time. This doesn't affect product quality. Wipe any liquid or dirt off the cap and store in a dry area.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton

WASO
SHISEIDO
GINZA TOKYO

KOSHIRICE

ACNE CALMING
TREATMENT

+ SALICYLIC ACID

SPOT CLEAR

RICE
HYOGO

20mL NET WT. .7 OZ.

PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton

SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-615
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.1 g in 20 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
GLYCERIN (UNII: PDC6A3C0OX)
ERYTHRITOL (UNII: RA96B954X6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
TANGERINE PEEL (UNII: JU3D414057)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BENZOIC ACID (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-615-60	1 in 1 CARTON	01/01/2021
1		20 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 DRUG	M006	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
Shiseido America Inc.		782677132	ANALYSIS(58411-615) , MANUFACTURE(58411-615)