Label: PROACTIV SOLUTION KIT- solutions kit kit
- NDC Code(s): 11410-005-20, 11410-040-15, 11410-215-30, 11410-215-60
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 30, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Renewing Cleanser - Drug Facts
- Repairing Treatment - Drug Facts
- Renewing Cleanser- Active ingredient
- Repairing Treatment - Active Ingredient
- Renewing Cleanser - Purpose
- Repairing Treatment - Purpose
- Renewing Cleanser - Use
- Repairing Treatment - Use
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Renewing Cleanser - Warnings
For external use only
Renewing Cleanser - 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.
- Repairing Treatment - Warnings
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Renewing Cleanser - 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 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.
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Repairing Treatment - 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 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.
- Renewing Cleanser - Do not use if you
- Repairing Treatment - Do not use if you
- Renewing Cleanser - Stop use and ask a doctor if
- Repairing Treatment - Stop use and ask a doctor if
- Renewing Cleanser - Keep out of reach of children
- Repairing Treatment - Keep out of reach of children
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Renewing Cleanser - 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.
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Repairing Treatment - 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.
clear 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.
- Renewing Cleanser - Other information
- Repairing Treatment - Other Informations
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Renewing Cleanser - 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
- Repairing Treatment - Inactive Ingredient
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - Proactiv Solution Kit
proactiv®
Proactiv Solution
3-step acne treatment system
Featuring micronized benzoyl peroxide
Step 1: Cleanse
Washes away debris & treats acne
Step 2: Tone
Refreshes & removes impurities
Step 3: Repair
Helps Kill acne-causing bacteria
Kits Contains: RENEWING CLEANSER 2 FL. OZ. (60 mL) Revitalizing Toner 2 FL. OZ. (60 mL) Repairing Treatment 1 FL. OZ. (30mL)
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INGREDIENTS AND APPEARANCE
PROACTIV SOLUTION KIT
solutions kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-215 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-215-30 1 in 1 BOX; Type 0: Not a Combination Product 05/08/2024 2 NDC:11410-215-60 1 in 1 BOX; Type 0: Not a Combination Product 05/08/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 60 mL in 100 Part 2 1 BOTTLE 60 mL in 100 Part 3 1 BOTTLE, PLASTIC 60 mL in 100 Part 1 of 3 PROACTIV RENEWING CLEANSER
benzoyl peroxide gelProduct Information 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) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) TRIDECYL STEARATE (UNII: A8OE252M6L) CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) PARAFFIN (UNII: I9O0E3H2ZE) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITOL (UNII: 506T60A25R) TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLPARABEN (UNII: Z8IX2SC1OH) PEG-100 STEARATE (UNII: YD01N1999R) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) CETYL ESTERS WAX (UNII: D072FFP9GU) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-005-20 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 Drug M006 10/21/2011 Part 2 of 3 REVITALIZING TONER
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] liquidProduct Information Route of Administration TOPICAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/08/2024 Part 3 of 3 PROACTIV REPAIRING TREATMENT
benzoyl peroxide gelProduct Information 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-100 STEARATE (UNII: YD01N1999R) PANTHENOL (UNII: WV9CM0O67Z) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ALLANTOIN (UNII: 344S277G0Z) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-040-15 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 05/08/2024 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 manufacture(11410-215) Establishment Name Address ID/FEI Business Operations VEE PAK, LLC 874763303 manufacture(11410-215)