Label: PROACTIV REPAIRING TREATMENT- benzoyl peroxide gel
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NDC Code(s):
11410-040-00,
11410-040-05,
11410-040-15,
11410-040-25, view more11410-040-30, 11410-040-35, 11410-040-45
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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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.
- 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.
Do notuse if you
▪ have very sensitive skin
▪ are sensitive to benzoyl peroxide -
Directions
- Sensitivity Test for a New User . Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- cleanse the skin thoroughly before applying this product.
- 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.
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Inactive Ingredients
water, ethoxydiglycol, cyclopentasiloxane, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, diazolidinyl urea, carbomer, fragrance, methylparaben, xanthan gum, panthenol, allantoin,, sodium hydroxide, propylparaben
Questions or comments? 1-800-950-4695
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Carton proactiv ® RepairingTreatment Benzoyl peroxide acne medication Step 3: Repair Proactiv Solution ®
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INGREDIENTS AND APPEARANCE
PROACTIV REPAIRING TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-040 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 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 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) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-040-00 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2011 2 NDC:11410-040-15 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2011 3 NDC:11410-040-30 1 in 1 BOX 11/01/2011 3 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:11410-040-25 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2011 5 NDC:11410-040-35 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2011 6 NDC:11410-040-05 1 in 1 BOX 03/25/2022 6 10 mL in 1 TUBE; Type 0: Not a Combination Product 7 NDC:11410-040-45 1 in 1 BOX 01/01/2021 7 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 11/01/2011 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations VEE PAK, LLC 874763303 manufacture(11410-040) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 manufacture(11410-040)