Label: SALICYLIC ACID soap

  • 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 May 4, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    • For the treatment of acne
    • Reduces the number of acne pimples and allows skin to heal
    • Penetrates pores to clear most acne blemishes
    • Dries up acne pimples
    • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor.

  • 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

    • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eyes.
    • Rinse thoroughly and pat dry with a clean towel
    • Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
    • Lot number and expiration date are printed on back panel.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, pentasodium pentetate, tocopheryl acetate (vitamin E)

  • QUESTIONS

    Questions?

    1-800-827-3730

    www.dermaharmony.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc., Portland, ME 04101

    Made in the USA

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    Salicylic Acid SOAP

    For Acne, Whiteheads, & Blackheads

    NET WT 4.0 OZ (113 G)

    SalicylicAcid-FINAL 05-07-18

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-003-04113 g in 1 CELLO PACK; Type 0: Not a Combination Product05/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/04/2018
    Labeler - D3 Development, Inc. (043195877)
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