Label: SENOPHILE DERMAL- petrolatum, cod liver ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Active Ingredient

    Petrolatum 30.00%

    Cod Liver Oil 10.00%

  • Purpose:

    Skin Protectant

    Skin Protectant

    Uses:

    • Temporarily protects minor cuts, scrapes, burns
    • Temporarily protects chapped or cracked skin.
    • Helps protect from the drying effects of wind and cold weather.
  • Warnings

    For external use only;

  • When using this product,

    do not get into eyes.

  • STOP USE

    If condition worsens or does not improve for seven days, discontinue use and consult a physician.

  • DO NOT USE

    DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN.

  • Keep out of reach of children.

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

  • Directions

    Apply as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a spatula, covering the entire surface with a thin layer. Place bandage directly on top of affected area. Make sure affected area remains covered by ointment.

  • Inactive ingredients

    Beeswax, BHT, Helianthus Annuus (Sunflower) Oil, Prunus Amygdalus Dulcis (sweet almond) Oil.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY:

    Pure Source, Inc.

    9750N.W 17th Stre et, Miami, Flo ri da 33.172 - USA

    IMPORTED BY:

    Laboratór io D audt Oliveira LTDA.

    Rua Simõe s da Mot a, 57 - Rio de Ja neiro - RJ

    CNPJ: 33.026.055/0001-20

    LICENSED BY:

    Rev Pharma Curefini.

    US Pate nt Nº 7,357,923

    Te chnical r esp onsible: Michele Vieira Esp índola - CRF / RJ 17419

    Register ANVISA nº: XXXXXXXXXXX

    BRAZILIAN INDUSTRY sac@grupodaudt.com.br

  • Package Label

    Senophile

    Dermal Ointment

    for cuts & burns

    208g

    label

  • INGREDIENTS AND APPEARANCE
    SENOPHILE DERMAL 
    petrolatum, cod liver ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40 g  in 100 g
    COD LIVER OIL (UNII: BBL281NWFG) (COD LIVER OIL - UNII:BBL281NWFG) COD LIVER OIL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-208-20208 g in 1 JAR; Type 0: Not a Combination Product02/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/24/2014
    Labeler - Pure Source, LLC (080354456)
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