3 STEP ACNE SYSTEM WELL AT WALGREENS- benzoyl peroxide 
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient                      Purpose

Benzoyl Peroxide - 2.50%         Acne Treatment

Uses

• Treats and helps prevent acne blemishes.

​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

Uses

• Treats and helps prevent acne blemishes.

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

• 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

image description

Ucarton back

3 STEP ACNE SYSTEM  WELL AT WALGREENS
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3226
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-3226-071 in 1 KIT07/15/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 120 mL
Part 21 BOTTLE 60 mL
Part 1 of 2
CLARIFYING CLEANSER STEP 1 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:0363-3227
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-3227-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/15/2014
Part 2 of 2
REPAIRTHERAPY STEP 3 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:0363-3228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-3228-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/15/2014
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(0363-3226) , label(0363-3226) , pack(0363-3226)

Revised: 2/2018
Document Id: 2c791796-51a2-4d1b-ae9a-14e16b5d5b79
Set id: eddc5d88-7812-49f6-b1c0-a12230e2528c
Version: 2
Effective Time: 20180222
 
Walgreens