Label: ACNE CONTROL RAPID RELIEF ACNE SPOT TREATMENT- salicylic acid solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70381-117-01, 70381-117-02 - Packager: Murad, 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 July 6, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- clean the skin thoroughly before applying 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 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 (Aqua), Alcohol, Hamamelis Virginiana (Witch Hazel) Water, Propanediol, Pentylene Glycol, Glycerin, Silica, Butylene Glycol, Polyacrylate Crosspolymer-6, C12-15 Alkyl Lactate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Avena Sativa (Oat) Kernel Extract, Urea, Yeast Amino Acids, Trehalose, Inositol, Taurine, Betaine, Thymol, Terpineol, Hydroxyphenyl Propamidobenzoic Acid, Shea Butter Ethyl Esters, 4-t-Butylcyclohexanol, Disodium EDTA, Sodium Hydroxide
- Other information
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- PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ACNE CONTROL RAPID RELIEF ACNE SPOT TREATMENT
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70381-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) PROPANEDIOL (UNII: 5965N8W85T) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) HORSE CHESTNUT (UNII: 3C18L6RJAZ) OAT (UNII: Z6J799EAJK) UREA (UNII: 8W8T17847W) AMINO ACIDS, SOURCE UNSPECIFIED (UNII: 0O72R8RF8A) TREHALOSE (UNII: B8WCK70T7I) INOSITOL (UNII: 4L6452S749) TAURINE (UNII: 1EQV5MLY3D) BETAINE (UNII: 3SCV180C9W) THYMOL (UNII: 3J50XA376E) TERPINEOL (UNII: R53Q4ZWC99) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color WHITE (Off-White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70381-117-02 1 in 1 CARTON 07/28/2021 1 NDC:70381-117-01 15 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 07/28/2021 Labeler - Murad, LLC (781254792) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 052400223 MANUFACTURE(70381-117)
