ACNEFREE SENSITIVE 24 HOUR ACNE CLEARING SYSTEM- benzoyl peroxide kit

AcneFree Sensitive by

Drug Labeling and Warnings

AcneFree Sensitive by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Hydrating Acne Repair Lotion + Spot Treatment

Drug Facts

Active ingredient

Benzoyl Peroxide 3% w/v

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only.

Do not use

• If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.

Ask a doctor or pharmacist before use

• If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness, or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

When using this product

• Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor

if excessive irritation occurs.

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

Directions

•   Apply to affected areas, avoiding eye area. Do not rinse. May also be used on face, chest, and back or throughout the day as a spot treatment. Recommended: Use as a spot treatment to start. Before using all-over face, gradually build skin’s tolerance by applying once every other night, then increasing application up to twice a day, morning and night.

Inactive Ingredients

Water, Ethyl Macadamiate, Propanediol, Glycerin, Butylene Glycol, Polyacrylamide, Phenoxyethanol, C13-14 Isoparaffin, Bisabolol, Laureth-7, Allantoin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Sodium Hyaluronate, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Hydroxide, Sea Whip Extract, Zingiber Officinale (Ginger) Root Extract

Other information

Store at 60°-95° F (15°-35° C).

Questions/Comments:

1-800-321-4576

Corrective Acne Cleanser

Drug Facts

Active ingredient

Salicylic Acid 1.5% w/v

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only.

Do not use

• If you have a known allergy to Salicylic Acid or aspirin.

When using this product

• with other topical acne medications at the same time or immediately following use of the product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.
• Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
• If you have aspirin sensitivity, consult a physician prior to use.

Stop use and ask a doctor

• if excessive irritation occurs.

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

Directions

Use every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome peeling occurs, reduce application use. May also be used on chest or back.

Inactive Ingredients

Water, Sodium Cocoyl Isethionate, Stearic Acid, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Disodium Laureth Sulfosuccinate, Glycol Distearate, Polyacrylate-1 Crosspolymer, Benzyl Alcohol, Avena Sativa (Oat) Kernel Extract, Sodium Phytate, Zinc PCA, Glycerin, Sorbic Acid, Ethyl Vanillin, Butylene Glycol, Sea Whip Extract, Aminomethyl Propanol

Other information

Store at 60°-95° F (15°-35° C).

Questions/Comments:

1-800-321-4576

Alcohol-Free Acne Toner

Warning:

For external use only.

Directions

Use every morning and evening. After cleansing, apply to entire face with a cotton pad, avoiding the eye area. Do not rinse. May also be used on chest or back.

Ingredients

Water, Niacinamide, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Extract, Sea Whip Extract, Saccharum Officinarum (Sugar Cane) Extract, Zingiber Officinale (Ginger) Root Extract, Pentylene Glycol, Benzyl Alcohol, Isoceteth-20, Aminomethyl Propanol, Salicylic Acid, Disodium EDTA, Bisabolol, Benzalkonium Chloride, Glycerin, Sorbic Acid, Butylene Glycol

Questions/Comments:

1-800-321-4576

SPL UNCLASSIFIED SECTION

Distributed by: Valeant Consumer Products,

a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

acnefree.com Made in USA ©2014 Rev. 03/14 9385400

PRINCIPAL DISPLAY PANEL - Kit Carton Label

AcneFree®

SENSITIVE

Sensitive Skin

24 HOUR Acne Clearing System

MORE

GENTLE than

PROACTIV*®

the ONLY Sensitive Skin

24 HOUR Acne Clearing System

DERMATOLOGIST RECOMMENDED ACNE MEDICATION

Gentle on Skin – Hydrates & Minimizes Overdrying

Tough on Acne – Starts Clearing in 1-3 Days

CONTAINS: CLEANSER 4 FL OZ (118 mL), TONER 4 FL OZ (118 mL), LOTION 2 FL OZ (59 mL)

Principal Display Panel- 24 HOUR Acne Clearing System

Principal Display Panel

AcneFree®

SENSITIVE

Hydrating

Acne Repair Lotion

+ Spot Treatment

Gentle Formula

___________________

Continuous-Relief

Micro-Benzoyl Peroxide

Principal Display Panel

AcneFree®

SENSITIVE

Corrective

Acne Cleanser

Gentle Formula

___________________

with Oat and Sea Whip

INGREDIENTS AND APPEARANCE

ACNEFREE SENSITIVE  24 HOUR ACNE CLEARING SYSTEM
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1612

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1612-03	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	59 mL
Part 2	1 TUBE	118 mL

Part 1 of 2

ACNEFREE SENSITIVE  HYDRATING ACNE REPAIR AND SPOT TREATMENT
benzoyl peroxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LEVOMENOL (UNII: 24WE03BX2T)
LAURETH-7 (UNII: Z95S6G8201)
ALLANTOIN (UNII: 344S277G0Z)
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/11/2014

Part 2 of 2

ACNEFREE SENSITIVE  CORRECTIVE ACNE CLEANSER
salicylic acid liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHYTATE SODIUM (UNII: 88496G1ERL)
ZINC PIDOLATE (UNII: C32PQ86DH4)
GLYCERIN (UNII: PDC6A3C0OX)
SORBIC ACID (UNII: X045WJ989B)
ETHYL VANILLIN (UNII: YC9ST449YJ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/11/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1612)