PHOTO FINISH MORE THAN PRIMER BLEMISH CONTROL- salicylic acid cream

PHOTO FINISH MORE THAN PRIMER BLEMISH CONTROL by

Drug Labeling and Warnings

PHOTO FINISH MORE THAN PRIMER BLEMISH CONTROL by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, 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., MANA PRODUCTS, INC., MANA Products,INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Salicylic acid 2.00%

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 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

• 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

Water\Aqua\Eau, Squalane, Dimethicone, Glycerin, Silica, Cetearyl Alcohol, Polyacrylamide, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Cinnamomum Zeylanicum Bark Extract, Honey Extract\Mel\Extrait De Miel, Panthenol, Sarcosin, C13-14 Isoparaffin, Coco-Glucoside, Capryloyl Glycine, Sodium Hydroxide, Xanthan Gum, Laureth-7, Allyl Methacrylates Crosspolymer, Butylene Glycol, Disodium EDTA, Phenoxyethanol <ILN39895>

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

smashbox

PHOTO FINISH
MORE THAN PRIMER

BLEMISH CONTROL
SALICYLIC ACID ACNE TREATMENT

OIL FREE

1 fl. oz. / 30 ml e

INGREDIENTS AND APPEARANCE

PHOTO FINISH MORE THAN PRIMER BLEMISH CONTROL 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Squalane (UNII: GW89575KF9)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cinnamon Bark Oil (UNII: XE54U569EC)
Honey (UNII: Y9H1V576FH)
Panthenol (UNII: WV9CM0O67Z)
Sarcosine (UNII: Z711V88R5F)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Coco Glucoside (UNII: ICS790225B)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
Sodium Hydroxide (UNII: 55X04QC32I)
Xanthan Gum (UNII: TTV12P4NEE)
Laureth-7 (UNII: Z95S6G8201)
Butylene Glycol (UNII: 3XUS85K0RA)
Edetate Disodium (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-008-01	1 in 1 CARTON	02/01/2013
1		30 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	02/01/2013

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(10348-008) , REPACK(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(10348-008) , REPACK(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(10348-008) , REPACK(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	MANUFACTURE(10348-008)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products,INC		032870270	MANUFACTURE(10348-008)