Label: PROACTIV CLEAN MINERAL ACNE CLEANSER- sulfur cream
- NDC Code(s): 11410-453-00, 11410-453-05
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 16, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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.
- 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.
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)
INGREDIENTS AND APPEARANCE
PROACTIV CLEAN MINERAL ACNE CLEANSER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-453 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:11410-453-00 1 in 1 BOX 08/15/2022 1 60 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11410-453-05 1 in 1 BOX 08/15/2022 2 177.4 mL in 1 TUBE; 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 08/15/2022 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 manufacture(11410-453)