ACNE SOLUTIONS CLEANSING BAR FOR FACE AND BODY- salicylic acid soap

ACNE solutions by

Drug Labeling and Warnings

ACNE solutions by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., TWINCRAFT INC. 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 the 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use hands to work into lather
• massage gently over wet skin, avoiding eye area
• rinse
• use AM and PM
• if bothersome drying or peeling occurs, reduce usage to every other day
• after acne clears, continue using for preventative care
• follow with Acne Solutions Clarifying Lotion

Inactive ingredients

sodium palmate sodium cocoate water palmitic acid cocamidopropyl dimethylamine glyceryl stearate zea mays (corn) starch hydrolyzed corn starch glycerin caffeine zinc pca ppg-26/dirner dilinoleate copolymer polyquaternium-67 hydrolyzed corn starch octenylsuccinate sodium chloride tetrasodium edta tetrasodium etidronate chlorphenesin titanium dioxide (cl 77891) [lln32953]

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 150 g Carton

C
CLINIQUE

acne solutions

cleansing bar
for face and body

STEP 1 SALICYLIC ACID ACNE MEDICATION
ALL SKIN TYPES

NET WT. 5.2 OZ./150 g e

INGREDIENTS AND APPEARANCE

ACNE SOLUTIONS   CLEANSING BAR FOR FACE AND BODY
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
sodium palmate (UNII: S0A6004K3Z)
sodium cocoate (UNII: R1TQH25F4I)
water (UNII: 059QF0KO0R)
palmitic acid (UNII: 2V16EO95H1)
glyceryl monostearate (UNII: 230OU9XXE4)
starch, corn (UNII: O8232NY3SJ)
glycerin (UNII: PDC6A3C0OX)
caffeine (UNII: 3G6A5W338E)
zinc pidolate (UNII: C32PQ86DH4)
sodium chloride (UNII: 451W47IQ8X)
edetate sodium (UNII: MP1J8420LU)
etidronate tetrasodium (UNII: CZZ9T1T1X4)
chlorphenesin (UNII: I670DAL4SZ)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-999-01	150 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	04/01/2006

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-999) , REPACK(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-999) , REPACK(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-999) , REPACK(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-999)

Establishment
Name	Address	ID/FEI	Business Operations
TWINCRAFT		093248870	MANUFACTURE(49527-999)