Label: PROACTIV BLACKHEAD DISSOLVING- salicylic acid gel
- NDC Code(s): 11410-024-05
- 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
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Directions
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Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 uses. If no discomfort occurs, follow the directions stated below.
- clean the skin thoroughly before applying this product
- 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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Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 uses. If no discomfort occurs, follow the directions stated below.
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Inactive ingredients
water, dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, phenoxyethanol, fragrance, polyisobutene, caprylyl glycol, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, hexylene glycol, ethylhexylglycerin, bisabolol, lactic acid, polysorbate 20, ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, ethylhexyl salicylate, camellia sinensis leaf extract
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Box
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INGREDIENTS AND APPEARANCE
PROACTIV BLACKHEAD DISSOLVING
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-024 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 6 (UNII: XHK3U310BA) DIMETHICONOL (40 CST) (UNII: 343C7U75XW) PANTHENOL (UNII: WV9CM0O67Z) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SHEA BUTTER (UNII: K49155WL9Y) LEVOMENOL (UNII: 24WE03BX2T) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYSORBATE 20 (UNII: 7T1F30V5YH) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) AVOBENZONE (UNII: G63QQF2NOX) OCTINOXATE (UNII: 4Y5P7MUD51) OCTISALATE (UNII: 4X49Y0596W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG) PEG-80 SORBITAN LAURATE (UNII: 239B50Y732) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-024-05 1 in 1 BOX 05/01/2013 1 30 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 Drug M006 05/01/2013 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations VEE PAK, LLC 874763303 manufacture(11410-024) Establishment Name Address ID/FEI Business Operations Apex International Mfg LLC 079110793 manufacture(11410-024)