3 STEP ACNE SYSTEM WELL AT WALGREENS- benzoyl peroxide kit

3 Step Acne System by

Drug Labeling and Warnings

3 Step Acne System by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                      Purpose

Benzoyl Peroxide - 2.50%         Acne Treatment

PURPOSE

Uses

Treats and helps prevent acne blemishes.

WARNINGS

​Warnings
For external use only.

Do not use if you have very sensitive skin or if you 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 it gets in eyes avoid unnecessary sun exposure and use a sunscreen avoid contact with eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occurs, 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​ irritation becomes severe.

Keep out of reach of the children

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

Directions

Use morning and night. Apply a small (dime-sized) amount to dampened skin and gently massage. Rinse thoroughly with warm water. If bothersome dryness or peeling occurs, reduce application use. Follow with Refreshing Toner.

Inactive ingredients

Water, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Dimethyl Isosorbide, Disodium PEG-12 Dimethicone  Sulfosuccinate, Tridecyl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Polyethylene, Cetyl Esters, Anthemis Nobilis Flower Extract,
Sodium Hyaluronate, Sodium PCA, Xanthan Gum, Tridecyl Trimellitate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben,
Fragrance

Active ingredient                           Purpose

Benzoyl Peroxide - 2.50%               Acne Treatment

PURPOSE

Uses

Treats and helps prevent acne blemishes.

WarningsFor external use only.

Do not use if you have very sensitive skin or if you 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 it gets in eyes avoid unnecessary sun exposure and use a sunscreen avoid contact with eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occurs, 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 irritation becomes severe.

Keep out of reach of the children

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

Directions

Cleans the skin thoroughly before applying medication Cover the entire affected area one to three times a day   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, use a sunscreen.  If sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

Water, Ethoxydiglycol, Cyclotetrasiloxane, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Dimethicone, lyceryl Stearate, PEG-100 Stearate, Panthenol, Allantoin, Xanthan Gum, Ceteareth-20, Carbomer, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben,
Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3 STEP ACNE SYSTEM  WELL AT WALGREENS
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-3226

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-3226-07	1 in 1 KIT	07/15/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	120 mL
Part 2	1 BOTTLE	60 mL

Part 1 of 2

CLARIFYING CLEANSER STEP 1 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 0363-3227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	Benzoyl Peroxide	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Sorbitol (UNII: 506T60A25R)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Tridecyl Stearate (UNII: A8OE252M6L)
Neopentyl Glycol Dicaprylate/Dicaprate (UNII: VLW429K27K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
Xanthan Gum (UNII: TTV12P4NEE)
Tridecyl Trimellitate (UNII: FY36J270ES)
Propylene Glycol (UNII: 6DC9Q167V3)
IMIDUREA (UNII: M629807ATL)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-3227-04	120 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	07/15/2014

Part 2 of 2

REPAIRTHERAPY STEP 3 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 0363-3228
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	Benzoyl Peroxide	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Propylene Glycol (UNII: 6DC9Q167V3)
Dimethicone (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Panthenol (UNII: WV9CM0O67Z)
Allantoin (UNII: 344S277G0Z)
Xanthan Gum (UNII: TTV12P4NEE)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROLAMINE (UNII: 9O3K93S3TK)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-3228-02	60 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	07/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/15/2014

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(0363-3226) , label(0363-3226) , pack(0363-3226)