Label: 111MEDCO 2% SALICYLIC ACID CLEANSING BAR- 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 April 25, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Salicylic acid 2%

    Purpose

    Acne treatment

  • Uses

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

    For external use only

    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  healthcare provider.

    Keep out of reach of children.

    If swallowed, get medial help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eye 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 drying or peeling occurs, reduce application to once a day or every other day
  • Inactive ingredients

    Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, pink grapefruit extract, sodium chloride, pentasodium pentetate.
    (*may contain this ingredient)

  • Package Labeling: 111MedCo 2% Salicylic Acid Cleansing Bar, 4oz/113g (72811-000-04)

    Label

  • INGREDIENTS AND APPEARANCE
    111MEDCO 2% SALICYLIC ACID CLEANSING BAR 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72811-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72811-000-04113 g in 1 CARTON; Type 0: Not a Combination Product07/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2022
    Labeler - 111MedCo LLC (065115643)