Label: NIXODERM UNGUENTO- salicylic acid ointment

  • 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 February 10, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Salicylic Acid 2%

  • PURPOSE

    Acne Treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

  • INDICATIONS & USAGE

    For Skin Acne treatment

    For relief, irritation, redness and of Acne

    Indications:

    *For the treatment of Acne.  Clears up acne pimples and blemishes, and allows skin to heal. Helpsprevent new pimples and blemishes from forming.

  • DOSAGE & ADMINISTRATION

    Directions:

    *Clean the skin thoroughly before applying this product.

    *Cover the entire affected area with a thing layer one to three times daily, then gradually increase to two or three time 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

  • WARNINGS

    Warnings:

    *For external use only.

    *Avoid contact with eyes. If contact occurs, rinse thoroughly with water

    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 only topical acne medication at a time

    *Do not use without consulting a doctor if the condition appears over a large portion of the body.

    Store at room temperature.

  • INACTIVE INGREDIENT

    Other Ingredients: beeswax, BHT, benzoic acid, petrolatum, polysorbate 80, sulfur, zinc oxide.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NIXODERM UNGUENTO 
    salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70344-001
    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
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SULFUR (UNII: 70FD1KFU70)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70344-001-0120 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/10/2016
    Labeler - Laboratorios Incobra S.A. (880003157)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Incobra S.A.880003157manufacture(70344-001)
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