Label: PROACTIV RENEWING CLEANSER- benzoyl peroxide gel
-
NDC Code(s):
11410-005-00,
11410-005-01,
11410-005-05,
11410-005-10, view more11410-005-20, 11410-005-40, 11410-005-70, 11410-005-75, 11410-005-80
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 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
-
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.
-
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.
- cover the entire affected area with a thin layer and rinse thoroughlyone 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.
-
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, paraffin, cetyl esters, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, xanthan gum, imidazolidinyl urea, fragrance, methylparaben, sodium sulfate, propylparaben, sodium PCA, propylene glycol, anthemis nobilis flower extract, phenoxyethanol, sodium hyaluronate
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 mL CARTON
-
INGREDIENTS AND APPEARANCE
PROACTIV RENEWING CLEANSER
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-005 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) PARAFFIN (UNII: I9O0E3H2ZE) CETYL ESTERS WAX (UNII: D072FFP9GU) CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-005-00 1 in 1 CARTON 03/07/2017 1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:11410-005-05 1 in 1 CARTON 03/07/2017 2 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:11410-005-40 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/21/2011 4 NDC:11410-005-20 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/23/2019 5 NDC:11410-005-10 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/21/2011 6 NDC:11410-005-70 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/21/2011 7 NDC:11410-005-80 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/21/2011 8 NDC:11410-005-01 1 in 1 CARTON 03/07/2017 8 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:11410-005-75 1 in 1 CARTON 01/01/2020 9 177 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 Drug M006 10/21/2011 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations VEE PAK, LLC 874763303 manufacture(11410-005) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 manufacture(11410-005)