NEUTROGENA SKIN CLEARING BLEMISH CONCEALER - BUFF 09- salicylic acid cream NEUTROGENA SKIN CLEARING BLEMISH CONCEALER - FAIR 05- salicylic acid cream NEUTROGENA SKIN CLEARING BLEMISH CONCEALER - LIGHT 10- salicylic acid cream NEUTROGENA SKIN CLEARING BLEMISH CONCEALER - MEDIUM 15- salicylic acid cream

Neutrogena by

Drug Labeling and Warnings

Neutrogena by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne medication

Use

For the treatment of acne.

Warnings

For external use only.

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• if eye contact occurs, flush thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store at room temperature.

Inactive ingredients

Water, cyclopentasiloxane, dimethicone, kaolin, cyclomethicone, VP/hexadecene copolymer, synthetic wax, cetyl PEG/PPG-10/1 dimethicone, trisiloxane, BIS-PEG/PPG-14/14 dimethicone, cyclohexasiloxane, butylene glycol, silica, phenoxyethanol, boron nitride, polysilicone-11, quaternium-90 bentonite, sodium chloride, magnesium sulfate, propylene glycol, methylparaben, farnesol, chamomilla recutita (matricaria) flower extract, propylene carbonate, triethoxycaprylylsilane, propylparaben, aloe barbadensis leaf juice, polymethyl methacrylate, tocopheryl acetate, cocamidopropyl PG-dimonium chloride phosphate, cetyl lactate, C12-15 alkyl lactate, benzalkonium chloride, retinyl palmitate, pantothenic acid, ascorbic acid May Contain: titanium dioxide, iron oxides

Questions?

Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Dist. by
Neutrogena Corporation
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 1.4 g Applicator Blister Pack - Buff 09

Buff 09
SkinClearing
blemish concealer
Don't just
cover up.
Clear up!
powered by
MICROCLEAR®
------technology---------
Blemish
treatment
with
Salicylic
Acid

Conceals
and treats
blemishes

Natural-
looking
coverage

Neutrogena

NET WT
0.05 OZ.
(1.4g)

PRINCIPAL DISPLAY PANEL - 1.4 g Applicator Blister Pack - Fair 05

FAIR
05

SkinClearing
blemish concealer
Don't just
cover up.
Clear up!
powered by
MICROCLEAR®
------technology---------
Blemish
treatment
with
Salicylic
Acid

Conceals
and treats
blemishes

Natural-
looking
coverage

Neutrogena

NET WT
0.05 OZ.
(1.4g)

PRINCIPAL DISPLAY PANEL - 1.4 g Applicator Blister Pack - Light 10

LIGHT
10

SkinClearing
blemish concealer
Don't just
cover up.
Clear up!
powered by
MICROCLEAR®
------technology---------
Blemish
treatment
with
Salicylic
Acid

Conceals
and treats
blemishes

Natural-
looking
coverage

Neutrogena

NET WT
0.05 OZ.
(1.4g)

PRINCIPAL DISPLAY PANEL - 1.4 g Applicator Blister Pack - Medium 15

MEDIUM
15

SkinClearing
blemish concealer
Don't just
cover up.
Clear up!
powered by
MICROCLEAR®
------technology---------
Blemish
treatment
with
Salicylic
Acid

Conceals
and treats
blemishes

Natural-
looking
coverage

Neutrogena

NET WT
0.05 OZ.
(1.4g)

INGREDIENTS AND APPEARANCE

NEUTROGENA   SKIN CLEARING BLEMISH CONCEALER - BUFF 09
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Kaolin (UNII: 24H4NWX5CO)
Cyclomethicone (UNII: NMQ347994Z)
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)
Trisiloxane (UNII: 9G1ZW13R0G)
BIS-PEG/PPG-14/14 Dimethicone (UNII: X2I70H0QJE)
Cyclomethicone 6 (UNII: XHK3U310BA)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Boron Nitride (UNII: 2U4T60A6YD)
Sodium Chloride (UNII: 451W47IQ8X)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Methylparaben (UNII: A2I8C7HI9T)
Farnesol (UNII: EB41QIU6JL)
Chamomile (UNII: FGL3685T2X)
Propylene Carbonate (UNII: 8D08K3S51E)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Propylparaben (UNII: Z8IX2SC1OH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
Cetyl Lactate (UNII: A7EVH2RK4O)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-520-01	1 in 1 BLISTER PACK	02/05/2010
1		1.4 g in 1 APPLICATOR; 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	02/05/2010

NEUTROGENA   SKIN CLEARING BLEMISH CONCEALER - FAIR 05
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-519
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Kaolin (UNII: 24H4NWX5CO)
Cyclomethicone (UNII: NMQ347994Z)
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)
Trisiloxane (UNII: 9G1ZW13R0G)
BIS-PEG/PPG-14/14 Dimethicone (UNII: X2I70H0QJE)
Cyclomethicone 6 (UNII: XHK3U310BA)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Boron Nitride (UNII: 2U4T60A6YD)
Sodium Chloride (UNII: 451W47IQ8X)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Methylparaben (UNII: A2I8C7HI9T)
Farnesol (UNII: EB41QIU6JL)
Chamomile (UNII: FGL3685T2X)
Propylene Carbonate (UNII: 8D08K3S51E)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Propylparaben (UNII: Z8IX2SC1OH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
Cetyl Lactate (UNII: A7EVH2RK4O)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-519-01	1 in 1 BLISTER PACK	02/05/2010
1		1.4 g in 1 APPLICATOR; 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	02/05/2010

NEUTROGENA   SKIN CLEARING BLEMISH CONCEALER - LIGHT 10
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-521
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Kaolin (UNII: 24H4NWX5CO)
Cyclomethicone (UNII: NMQ347994Z)
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)
Trisiloxane (UNII: 9G1ZW13R0G)
BIS-PEG/PPG-14/14 Dimethicone (UNII: X2I70H0QJE)
Cyclomethicone 6 (UNII: XHK3U310BA)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Boron Nitride (UNII: 2U4T60A6YD)
Sodium Chloride (UNII: 451W47IQ8X)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Methylparaben (UNII: A2I8C7HI9T)
Farnesol (UNII: EB41QIU6JL)
Chamomile (UNII: FGL3685T2X)
Propylene Carbonate (UNII: 8D08K3S51E)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Propylparaben (UNII: Z8IX2SC1OH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
Cetyl Lactate (UNII: A7EVH2RK4O)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-521-01	1 in 1 BLISTER PACK	02/05/2010
1		1.4 g in 1 APPLICATOR; 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	02/05/2010

NEUTROGENA   SKIN CLEARING BLEMISH CONCEALER - MEDIUM 15
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Kaolin (UNII: 24H4NWX5CO)
Cyclomethicone (UNII: NMQ347994Z)
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)
Trisiloxane (UNII: 9G1ZW13R0G)
BIS-PEG/PPG-14/14 Dimethicone (UNII: X2I70H0QJE)
Cyclomethicone 6 (UNII: XHK3U310BA)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Boron Nitride (UNII: 2U4T60A6YD)
Sodium Chloride (UNII: 451W47IQ8X)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Methylparaben (UNII: A2I8C7HI9T)
Farnesol (UNII: EB41QIU6JL)
Chamomile (UNII: FGL3685T2X)
Propylene Carbonate (UNII: 8D08K3S51E)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Propylparaben (UNII: Z8IX2SC1OH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
Cetyl Lactate (UNII: A7EVH2RK4O)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-522-01	1 in 1 BLISTER PACK	02/05/2010
1		1.4 g in 1 APPLICATOR; 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	02/05/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)