Label: BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION- salicylic acid cream
- NDC Code(s): 49527-062-01, 49527-062-02
- Packager: CLINIQUE LABORATORIES 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.
Drug Label Information
Updated January 9, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
water\aqua\eau • kaolin • glycerin • butylene glycol • magnesium aluminum silicate • glyceryl stearate • peg-100 stearate • silica • sodium lauroyl sarcosinate • allyl methacrylates crosspolymer • gentiana lutea (gentian) root extract • laminaria saccharina extract • sucrose • acetyl glucosamine • caprylyl glycol • 1,2-hexanediol • tocopheryl acetate • sodium hydroxide • xanthan gum • disodium edta • phenoxyethanol • titanium dioxide (ci 77891) • blue 1 (ci 42090) • yellow 5 (ci 19140) [iln43442]
- PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-062 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) KAOLIN (UNII: 24H4NWX5CO) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SUCROSE (UNII: C151H8M554) N-ACETYLGLUCOSAMINE (UNII: V956696549) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-062-01 1 in 1 CARTON 08/30/2018 11/30/2022 1 20 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49527-062-02 1 in 1 CARTON 08/01/2022 2 125 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 M006 08/30/2018 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(49527-062) , label(49527-062) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(49527-062) , label(49527-062) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(49527-062) , pack(49527-062) , label(49527-062) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-062) , pack(49527-062) , label(49527-062) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(49527-062) , label(49527-062) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(49527-062) , label(49527-062)