CLEAR DIFFERENCE TARGETED BLEMISH TREATMENT- salicylic acid lotion

CLEAR DIFFERENCE TARGETED BLEMISH TREATMENT by

Drug Labeling and Warnings

CLEAR DIFFERENCE TARGETED BLEMISH TREATMENT by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 1.00%

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

Directions

• cleanse skin thoroughly before applying
• cover the entire affected area with one application daily
• gradually increase to 2 or 3 times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to every other day

Inactive ingredients

alcohol denat. water\aqua\eau acetyl glucosamine acrylates/c10-30 alkyl acrylate crosspolymer algae extract laminaria saccharina extract hypnea musciformis (algae) extract gellidiela acerosa (algae) extract hamamelis virginiana (witch hazel) extract caffeine sucrose butylene glycol fragrance (parfum) phenoxyethanol <iln40166>

PRINCIPAL DISPLAY PANEL - 4 ml Tube Carton

ESTĒE LAUDER

Clear
Difference

Targeted
Blemish Treatment

SALICYLIC ACID
ACNE TREATMENT

.14 FL. OZ. LIQ./4 ml

INGREDIENTS AND APPEARANCE

CLEAR DIFFERENCE TARGETED BLEMISH TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.0091 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)
GELIDIELLA ACEROSA (UNII: T91K54D6M1)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
CAFFEINE (UNII: 3G6A5W338E)
SUCROSE (UNII: C151H8M554)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-044-01	1 in 1 CARTON	10/01/2014
1		4 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	10/01/2014

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-044) , REPACK(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-044) , REPACK(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-044) , REPACK(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-044)