EXFOLUX (SALICYLIC ACID AND SULFUR) SHAMPOO [NOOTIE LLC]

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EXFOLUX (SALICYLIC ACID AND SULFUR) SHAMPOO [NOOTIE LLC]
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NDC 51437-105-04, 51437-105-16
Set ID a457253a-f085-45b6-8c37-6653e7ed32a9
Category OTC ANIMAL DRUG LABEL
Packager Nootie LLC
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active Ingredients:                  Purpose
    Sulfur                         2% …….....Antiseborrheic
    Salicylic Acid               2% …….…..Keratolytic

  • PRINCIPAL DISPLAY PANEL

    Shampoo 4 oz

    Shampoo 8 oz

    Shampoo 16 oz

  • INGREDIENTS AND APPEARANCE
    EXFOLUX 
    salicylic acid and sulfur shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51437-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51437-105-04118 mL in 1 BOTTLE, PLASTIC
    2NDC:51437-105-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2013
    Labeler - Nootie LLC (008995795)
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