Label: MULTI-ACTION CLEAR - ACNE CLEARING TREATMENT 2% SALICYLIC ACID- salicylic acid lotion

  • NDC Code(s): 76147-301-07, 76147-301-15, 76147-301-50
  • Packager: StriVectin Operating Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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  • ACTIVE INGREDIENTS

    SALICYLIC ACID 2%

  • PURPOSE

    ACNE MEDICATION

  • USES

    • For the treatment of acne.
    • Clears acne pimples.
    • Helps prevent new acne pimples from forming.
  • 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.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • DIRECTIONS

    • clean the skin thoroughly before applying this 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 to 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.
  • OTHER INFORMATION

    store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

  • INACTIVE INGREDIENTS

    Water/Aqua/Eau, Propanediol, Isononyl Isononanoate, Triheptanoin, C9-12 Alkane, Glyceryl Stearate, PEG-100 Stearate, Diheptyl Succinate, Isopentyldiol, Capryloyl Glycerin/Sebacic Acid Copolymer, Glycerin, Polyacrylate Crosspolymer-6, Cetyl Alcohol, Benzyl Alcohol, Saccharide Isomerate, Bakuchiol, Myristyl Nicotinate, Sodium Hydroxide, Coco-Caprylate/Caprate, Bisabolol, Xylitol, Caprylhydroxamic Acid, Xanthan Gum, Caprylic Acid, Fragrance (Parfum), Trifolium Pratense (Clover) Flower Extract, Pentylene Glycol, Beta-Glucan, Hydrolyzed Algin, Caprylyl Glycol, Backhousia Citriodora Leaf Extract, Carnitine, Citric Acid, Sodium Citrate, Zingiber Officinale (Ginger) Root Extract, Polylysine, Geraniol, Linalool, Benzyl Salicylate [ILN 41338]

  • PRINCIPAL DISPLAY PANEL

    0-UC (US)_MA CLEAR ACNE LOTION

  • INGREDIENTS AND APPEARANCE
    MULTI-ACTION CLEAR - ACNE CLEARING TREATMENT  2% SALICYLIC ACID
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76147-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BAKUCHIOL (UNII: OT12HJU3AR)  
    MYRISTYL NICOTINATE (UNII: 8QWM6I035C)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)  
    GINGER (UNII: C5529G5JPQ)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARNITINE (UNII: S7UI8SM58A)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    WATER (UNII: 059QF0KO0R)  
    POLY-L-LYSINE (30000-70000 MW) (UNII: 0A1V8JTU2M)  
    GERANIOL (UNII: L837108USY)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76147-301-071 in 1 BOX01/09/2023
    17 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:76147-301-501 in 1 BOX01/09/2023
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:76147-301-151 in 1 KIT01/09/2023
    315 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/09/2023
    Labeler - StriVectin Operating Company, Inc. (832343722)
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