PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT- salicylic acid gel

PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT by

Drug Labeling and Warnings

PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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>

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

MAC
PREP+PRIME

BLEMISH
CONTROL GEL
SALICYLIC ACID
ACNE TREATMENT

15 ML/0.5 US FL OZ

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
hamamelis virginiana top (UNII: UDA30A2JJY)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
saccharina latissima (UNII: 68CMP2MB55)
butylene glycol (UNII: 3XUS85K0RA)
benzalkonium chloride (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2013

Labeler - MAKEUP ART COSMETICS (010597206)

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

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

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

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

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

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

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

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

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