Label: 3 STEP ACNE SYSTEM WELL AT WALGREENS- benzoyl peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-3226-07, 0363-3227-04, 0363-3228-02 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 22, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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WARNINGS
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. • 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.
- Directions
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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
- PURPOSE
- Uses
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WarningsFor 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. • 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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3 STEP ACNE SYSTEM WELL AT WALGREENS
benzoyl peroxide kitProduct 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 lotionProduct 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 lotionProduct 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)
