Label: SALICYLIC ACID CLEANSER- exfoliating and clarifying face wash gel

  • NDC Code(s): 54111-171-02, 54111-171-04
  • Packager: Bentley 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 July 1, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient
    Salicylic Acid 0.5%

  • PURPOSE

    Purpose
    Acne Treatment

  • INDICATIONS & USAGE

    Use for the management of acne.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    • Use twice a day, morning and night.
    • Lather between palms with water, massage in circular motion on
      wet skin, rinse well.
    • If bothersome dryness or peeling

  • OTHER SAFETY INFORMATION

    Other Information
    • Store in a cool, dry place.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Glycerin, Xanthan
    Gum, Polyglyceryl-4 Caprate, Polyglyceryl-4 Laurate/Sebacate,
    Propanediol, Phenoxyethanol, Sodium Lauroamphoacetate,
    Caprylyl Glycol, Allantoin, Eucalyptus Globulus Leaf Oil, Disodium
    EDTA, Sodium Hydroxide, Menthol, Bisabolol, Avena Sativa
    (Oat) Bran Extract, Camellia Sinensis Leaf Extract, Hamamelis
    Virginiana (Witch Hazel) Leaf Extract, Rosa Canina Fruit Extract,
    Leuconostoc/Radish Root Ferment Filtrate, Beta-Glucan, Zingiber
    Officinale (Ginger) Root Extract, Myristoyl Pentapeptide-17.

  • QUESTIONS

    Questions or comments?
    slmdskincare.com

  • Product Package for Salicylic Acid Cleanser

    SLMD​®

    Salicylic Acid
    Cleanser
    Exfoliating & Clarifying
    Face Wash

    Acne Treatment

    Treats and prevents acne and
    the appearance of dark spots.

    2.0 f l. oz. – 60 mL

    SANDRA LEE MD

    w w w.slmdskincare.com

    Distributed by Skin PS Brands
    Culver City, CA 90232

    Made in the USA with globally sourced materials.

    2 Oz.

    1042 2 Oz Crtn

    1042 2 Oz Tube

    4 Oz.

    1042 4 Oz Crtn

    1042 4 Oz Tube

    res

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID CLEANSER 
    exfoliating and clarifying face wash gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHOL (UNII: L7T10EIP3A)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    OAT BRAN (UNII: KQX236OK4U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)  
    GINGER (UNII: C5529G5JPQ)  
    MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-171-021 in 1 CARTON07/01/2023
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:54111-171-041 in 1 CARTON07/01/2023
    2118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2023
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Skin PS Brands (081085221)
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