Label: PROACTIV CLEAN MINERAL ACNE CLEANSER- sulfur cream
- NDC Code(s): 11410-457-00, 11410-457-05, 11410-457-10, 11410-457-15
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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- 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.
- apply only to areas with acne.
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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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, follows the directions stated below.
- cover the entire affected area with a thin layer and rinse thoroughly 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.
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Inactive ingredients
water, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 FL. OZ. (177.4 mL)
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INGREDIENTS AND APPEARANCE
PROACTIV CLEAN MINERAL ACNE CLEANSER
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-457 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) COCO GLUCOSIDE (UNII: ICS790225B) COCONUT ACID (UNII: 40U37V505D) COCONUT ALCOHOL (UNII: 13F4MW8Y9K) GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y) GLYCERETH-18 (UNII: SA5E43C17C) DOCOSANOL (UNII: 9G1OE216XY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM ISETHIONATE (UNII: 3R36J71C17) SODIUM HYDROXIDE (UNII: 55X04QC32I) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-457-05 1 in 1 BOX 08/15/2022 1 60 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11410-457-10 1 in 1 BOX 08/15/2022 2 177.4 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:11410-457-00 1 in 1 BOX 12/01/2022 3 10 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:11410-457-15 60 mL in 1 TUBE; Type 0: Not a Combination Product 01/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/15/2022 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 manufacture(11410-457)
