ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM- benzoyl peroxide kit

AcneFree Clear Skin Treatments by

Drug Labeling and Warnings

AcneFree Clear Skin Treatments by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Universal Packaging Systems, Inc., Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

24 hour Severe Acne Clearing System ANTI-ACNE CLEANSING WASH

Drug Facts

Active ingredient

Benzoyl Peroxide 2.5% w/v

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

Do not use if you

• ▪ have sensitive skin
• ▪ are sensitive to Benzoyl Peroxide

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.
• ▪ rinse right away with water if product gets in eyes
• ▪ avoid unnecessary sun exposure and use a sunscreen
• ▪ avoid contact with the eyes, lips and mouth
• ▪ avoid contact with hair and dyed fabrics, which may be bleached by this product
• ▪ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

skin irritation becomes severe

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

Directions

• ▪ Use every morning and evening.
• ▪ apply a dime-size amount to damp skin and gently massage, avoiding the eye area.
• ▪ rinse well
• ▪ use wash on entire affected area one to two times daily
• ▪ because excessive drying of the skin my occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor
• ▪ if bothersome dryness or peeling occurs, reduce cleansing to once a day or every other day
• ▪ if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of products and ask a doctor.
• ▪ May be used on chest or back.

Inactive ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP

Questions/comments

1-800-321-4576

24 HOUR Severe Acne Clearing System CORRECTIVE TONER

Warnings

For external use only

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. Wait 10 minutes between Steps 2 and 4.

Directions

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

Ingredients

water, SD alcohol 40, hamamelis virginiana (witch hazel) water, sorbitol, glycerin, polysorbate 20, alcohol, glycolic acid, sodium hydroxide, aloe barbadensis leaf juice, benzalkonium chloride, bisabolol, niacinamide, panthenol, propylene glycol, disodium EDTA, chamomilla recutita (matricaria) flower extract, copper PCA, lactic acid, butylene glycol, methylisothiazolinone, sea whip extract, phenoxyethanol, citric acid, leuconostoc/radish root ferment filtrate, methylparaben, butylparaben, ethylparaben, propylparaben, isobutylparaben

Questions/comments

1-800-321-4576

24 HOUR Acne Clearing System RETINOL COMPLEX

Warnings

For external use only.

When using this product avoid getting into eyes. If contact occurs, rinse thoroughly with water. If skin irritation occurs, wash product off and consult physician. When first applying this product, you may experience a slight tingling sensation. This is an indication that the product is working. If sensation is prolonged or becomes unpleasant, discontinue use and consult a physician. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product.

Directions

Apply only at night. Wait at least 10 minutes after applying Step 2 (until skin is dry), then use fingertips to massage into acne affected areas. Do not rinse off. For best results, do not use Retinol Complex at the same time as Step 3.

Ingredients

water, mineral oil, cetearyl alcohol, glycerin, dimethicone, glyceryl stearate, PEG-100 stearate, polysorbate 60, caprylic/capric triglyceride, cetyl alcohol, phenoxyethanol, bisabolol, retinol, xanthan gum, polysorbate 20, allantoin, C12-15 alkyl benzoate, disodium EDTA, methylparaben, cetyl palmitate, famesol, neopentyl glycol dicaprylate/dicaprate, tridecyl stearate, ceramide 3, triethanolamine, butylparaben, ethylparaben, propylparaben, isobutylparaben, cetyl triethylmonium dimethicone PEG-8 succinate, glycine sola (soybean) sterols, tridecyl trimellitate, sodium hyaluronate, methylisothiazolinone

Questions/comments

1-800-321-4576

24 HOUR Acne Clearing System MAXIMUM STRENGTH REPAIR LOTION

Drug Facts

Active ingredient

Benzoyl Peroxide 10% w/v

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

• ▪ have very sensitive skin
• ▪ are sensitive to Benzoyl Peroxide

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.
• ▪ rinse right away with water if product gets in eyes
• ▪ avoid unnecessary sun exposure and use a sunscreen
• ▪ avoid contact with the eyes, lips and mouth
• ▪ avoid contact with hair and dyed fabrics, which may be bleached by this product
• ▪ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration..

Stop use and ask a doctor if

skin irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• ▪ Use every morning after Step 2
• ▪ clean skin thoroughly before applying this product
• ▪ apply to entire face avoiding the eye area
• ▪ do not rinse
• ▪ 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
• ▪ if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• ▪ IMPORTANT: For best results, do not apply Steps 3 & 4 at the same time.

Inactive ingredients

water, butylene glycol, C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, phenoxyethanol, hydroxypropyl starch phosphate, polysorbate 60, dimethicone, xanthan gum, cetyl alcohol, bisabolol, tetrasodium EDTA, ethylhexylglycerin, methylisothiazolinone, benzalkonium chloride, sea whip extract, zingiber officinale (ginger) root extract, chamomilla recutita (matricaria) flower extract, alcohol, leuconostoc/radish root ferment filtrate, methylparaben, disodium EDTA, ethylparaben, methyl methacrylate/glycol dimethacrylate crosspolymer

Questions/comments

1-800-321-4576

PRINCIPAL DISPLAY PANEL - Kit Carton Label

AcneFree®

SEVERE

24 HOUR

Severe Acne Clearing System

AMERICA’S BEST SELLING

#1

Acne Treatment In Stores†

INCLUDES REPAIR LOTION POWERED BY ACNE-FIGHTING INGREDIENT 4XTHE CONCENTRATION LEVEL VS. PROACTIV*

When used as directed treats all stages of stubborn acne 24 hours a day

DERMATOLOGIST RECOMMENDED BENZOYL PEROXIDE

With Continuous Release Technology

CONTAINS: ANTI-ACNE CLEANSING WASH 4 FL OZ (118 mL), CORRECTIVE TONER 4 FL OZ (118 mL), MAXIMUM STRENGTH REPAIR LOTION 2 FL OZ (59 mL), RETINOL COMPLEX 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ACNEFREE CLEAR SKIN TREATMENTS  24 HOUR SEVERE ACNE CLEARING SYSTEM
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1611

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1611-04	1 in 1 CARTON; Type 0: Not a Combination Product	06/25/2014

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

Part 1 of 2

ACNEFREE SEVERE 
benzoyl peroxide cream

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	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
GLYCOLIC ACID (UNII: 0WT12SX38S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; 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	06/25/2014

Part 2 of 2

ACNEFREE SEVERE 
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	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
LEVOMENOL (UNII: 24WE03BX2T)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
GINGER (UNII: C5529G5JPQ)
CHAMOMILE (UNII: FGL3685T2X)
ALCOHOL (UNII: 3K9958V90M)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE; 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	06/25/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/25/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc.		790530976	MANUFACTURE(0187-1611)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1611)