CLEAR DIFFERENCE ADVANCED BLEMISH SERUM- salicylic acid lotion

CLEAR DIFFERENCE ADVANCED BLEMISH SERUM by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 0.50%

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 times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to every other day
• follow with your moisturizer

Inactive ingredients

water\aqua\eau dimethicone hamamelis virginiana (witch hazel) water ppg-14 butyl ether acetyl glucosamine sucrose isodecyl neopentanoate steareth-21 glycine acrylamide/sodium acryloyldimethyltaurate copolymer laminaria saccharina extract caffeine tocopheryl acetate isohexadecane steareth-2 algae extract sodium hyaluronate polysorbate 80 quaternium-22 butylene glycol sodium hydroxide pentylene glycol disodium edta fragrance (parfum) limonene linalool phenoxyethanol benzalkonium chloride green 5 (ci 61570) yellow 5 (ci 19140) <iln40165>

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

ESTĒE LAUDER

Clear
Difference
Advanced
Blemish Serum

SALICYLIC ACID ACNE TREATMENT

1.7 FL. OZ. LIQ./50 ml e

INGREDIENTS AND APPEARANCE

CLEAR DIFFERENCE ADVANCED BLEMISH SERUM 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.0053 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
hamamelis virginiana top water (UNII: NT00Y05A2V)
ppg-14 butyl ether (UNII: R199TJT95T)
n-acetylglucosamine (UNII: V956696549)
sucrose (UNII: C151H8M554)
isodecyl neopentanoate (UNII: W60VYE24XC)
steareth-21 (UNII: 53J3F32P58)
glycine (UNII: TE7660XO1C)
saccharina latissima (UNII: 68CMP2MB55)
caffeine (UNII: 3G6A5W338E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
isohexadecane (UNII: 918X1OUF1E)
steareth-2 (UNII: V56DFE46J5)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 80 (UNII: 6OZP39ZG8H)
quaternium-22 (UNII: MXO138JCBP)
butylene glycol (UNII: 3XUS85K0RA)
sodium hydroxide (UNII: 55X04QC32I)
pentylene glycol (UNII: 50C1307PZG)
edetate disodium (UNII: 7FLD91C86K)
linalool, (+/-)- (UNII: D81QY6I88E)
phenoxyethanol (UNII: HIE492ZZ3T)
benzalkonium chloride (UNII: F5UM2KM3W7)
D&C green no. 5 (UNII: 8J6RDU8L9X)
FD&C yellow no. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-041-01	1 in 1 CARTON	04/01/2014
1		50 mL in 1 BOTTLE; 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	04/01/2014

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-041) , REPACK(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		244669714	MANUFACTURE(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-041) , REPACK(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-041) , REPACK(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-041)