Label: DERMESSE PAD TREATMENT 0.5- 0.5%salicylic acid lotion
DERMESSE PAD TREATMENT 2.0- 2%salicylic acid lotion

  • 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 January 11, 2022

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

  • Active Ingredients

    0.5% Salicylic Acid

    2% Salicylic Acid

  • Purpose

    Acne Treatment

  • Uses:

    For the treatment of acne

  • Warninigs:

    For external use only

    Combustibles. Keep away from fire or flames.

  • Ask a doctor or pharmacist before use if you are:

    using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control center right away.

  • DIRECTIONS:

    • Cleanse the skin thoroughly before applying medication
    • 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 or three times daily if needed or directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • OTHER INFORMATION:

    Store at controlled room temperature 15-300C (59-860F), away from diret sunlight.

  • INACTIVE INGREDIENTS:

    Ammonium Hydroxide, Edetate Disodium, Ethyl Alcohol SD40, Glycolic Acid, Propylene Glycol, Purified Water, Nonoxynol 9.

  • PRINCIPAL DISPLAY PANEL

    Dermesse Pad Treatment 0.5

    Dermesse_AcnePads_0.5%

    Dermesse Pad Treatment 2.0

    Dermesse_AcnePads_2.0%

  • INGREDIENTS AND APPEARANCE
    DERMESSE PAD TREATMENT 0.5 
    0.5%salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68723-400-0560 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2022
    DERMESSE PAD TREATMENT 2.0 
    2%salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68723-401-2060 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2022
    Labeler - Axia Medical Solutions, LLC (929224694)
    Registrant - Axia Medical Solutions, LLC (929224694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanitor Corporation797472792manufacture(68723-400, 68723-401)