ACNE AND LINE CORRECTING SERUM- salicylic acid lotion

ACNE AND LINE CORRECTING SERUM by

Drug Labeling and Warnings

ACNE AND LINE CORRECTING SERUM by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.0%

Purpose

Acne Treatment

Uses

• treats acne
• clears acne blemishes
• helps prevent development of new acne blemishes

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply 2-3 drops twice a day all over face.

Inactive ingredients

water\aqua\eau dimethicone butylene glycol vinyl dimethicone/methicone silsesquioxane crosspolymer methyl trimethicone polysorbate 20 bis-peg-18 methyl ether dimethyl silane lauryl peg-9 polydimethylsiloxyethyl dimethicone glycerin methyl gluceth-20 polysilicone-11 oenothera biennis (evening primrose) flower extract glycine soja (soybean) seed extract sigesbeckia orientalis (st. paul's wort) extract salvia sclarea (clary) extract plankton extract laminaria saccharina extract acetyl hexapeptide-8 acetyl glucosamine caffeine gylcine soja (soybean) protein aminopropyl ascorbyl phosphate cholesterol caprylyl glycol micrococcus lysate palmitoyl hexapeptide-12 lecithin whey protein\lactis protein\protéine du petit-lait sodium hyaluronate tocopheryl acetate peg-8 sodium hydroxide ammonium acryloyldimethyltaurate/vp copolymer xanthan gum carbomer glyceryl polymethacrylate sodium benzoate sodium citrate disodium edta phenoxyethanol [iln42038]

Other information

Protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

© CLINIQUE LABORATORIES, DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

acne

C

CLINIQUE

acne solutions

acne + line
correcting
serum

SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES

1 FL.OZ.LIQ./30 ml e

INGREDIENTS AND APPEARANCE

ACNE AND LINE CORRECTING SERUM 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
methyl trimethicone (UNII: S73ZQI0GXM)
polysorbate 20 (UNII: 7T1F30V5YH)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
glycerin (UNII: PDC6A3C0OX)
methyl gluceth-20 (UNII: J3QD0LD11P)
dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
oenothera biennis flower (UNII: Y1YXJ1M6Z5)
soybean (UNII: L7HT8F1ZOD)
saccharina latissima (UNII: 68CMP2MB55)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
n-acetylglucosamine (UNII: V956696549)
caffeine (UNII: 3G6A5W338E)
soy protein (UNII: R44IWB3RN5)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
cholesterol (UNII: 97C5T2UQ7J)
caprylyl glycol (UNII: 00YIU5438U)
palmitoyl hexapeptide-12 (UNII: HO4ZT5S86C)
whey (UNII: 8617Z5FMF6)
hyaluronate sodium (UNII: YSE9PPT4TH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
polyethylene glycol 400 (UNII: B697894SGQ)
sodium hydroxide (UNII: 55X04QC32I)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
xanthan gum (UNII: TTV12P4NEE)
carboxypolymethylene (UNII: 0A5MM307FC)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-053-01	1 in 1 CARTON	08/15/2016
1		30 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	08/15/2016

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-053) , REPACK(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-053) , REPACK(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-053) , REPACK(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-053)