ACNE CLEANSING- salicylic acid gel

ACNE CLEANSING by

Drug Labeling and Warnings

ACNE CLEANSING 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 2%

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

• Wet hands and work into a lather
• Add water to increase lather
• Massage gently over wet skin, avoiding eye area
• Rinse
• Use A.M. and P.M.
• If bothersome drying or peeling occurs, reduce usage to every other day
• Follow with Acne Solutions Clarifying Lotion

Inactive ingredients

water\aqua\eau glycerin sodium laureth sulfate sodium chloride lauramidopropyl betaine butylene glycol sucrose gentiana lutea (gentian) root extract laminaria saccharina extract caffeine sodium hyaluronate acetyl glucosamine laureth-2 peg-120 methyl glucose dioleate sodium sulfate benzophenone-4 sodium hydroxide edta disodium edta bht phenoxyethanol blue 1 (ci 42090) [iln41073]

Other information

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

PRINCIPAL DISPLAY PANEL - 125 mL Tube Carton

acne

C
CLINIQUE

acne solutions
cleansing gel

SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES

4.2 FL.OZ.LIQ./125 ml e

INGREDIENTS AND APPEARANCE

ACNE CLEANSING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02158 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SUCROSE (UNII: C151H8M554)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
CAFFEINE (UNII: 3G6A5W338E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
LAURETH-2 (UNII: D4D38LT1L5)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM SULFATE (UNII: 0YPR65R21J)
SULISOBENZONE (UNII: 1W6L629B4K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETIC ACID (UNII: 9G34HU7RV0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-045-01	1 in 1 CARTON	10/01/2014
1		125 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 - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-045) , REPACK(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-045) , REPACK(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-045) , REPACK(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-045)