PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT- salicylic acid gel
MAKEUP ART COSMETICS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT

Drug Facts

Active Ingredients

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 the 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 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, acrylates/c10-30 alkyl acrylate crosspolymer, hamamelis virginiana (witch hazel) extract, sea whip extract, laminaria saccharina extract, butylene glycol, benzalkonium chloride <iln39480>

DIST. BY/PAR: MAKE-UP ART COSMETICS TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

M•A•C
PREP+PRIME

BLEMISH
CONTROL GEL
SALICYLIC ACID
ACNE TREATMENT

15 ML/0.5 US FL OZ

Principal Display Panel - 15 mL Tube Carton

PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40046-0068
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.008776 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:40046-0068-1	1 in 1 CARTON	01/01/2013
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	01/01/2013	11/12/2020

Labeler - MAKEUP ART COSMETICS (010597206)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0068) , REPACK(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder N.V.		370151326	MANUFACTURE(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC INC		943871157	RELABEL(40046-0068) , REPACK(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	RELABEL(40046-0068) , REPACK(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0068)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0068)

Revised: 12/2018

Document Id: bc6e67e6-1044-47b9-8d52-11498e805b85

Set id: fa043bbd-84d4-47d7-9c1d-5a71c196cc46

Version: 3

Effective Time: 20181214

MAKEUP ART COSMETICS