Label: CLASSIC LIME SULFUR- lime sulfur cream

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Description:
    Lime Sulfur cream is for treatment of non-specific dermatitis and parasites in dogs, cats, puppies and kittens. Antimicrobial and Antifungal properties of Lime Sulfur treat mange, ringworm, fungus and scabies. Essential oils and cream base promote hair growth and relieve dry skin.

    Warning:
    Keep out of reach of children. Do not allow animal to ingest. Apply a protective collar, if necessary, to prevent ingestion.

    Storage:
    Store in dry and cool place away from sunlight and extreme temperatures.

    Directions:
    Apply Lime Sulfur cream over the affected area until the area is fully covered. Treat once daily for one week then twice per week for two more weeks. If needed, continue to use every week for additional weeks or as directed by your veterinarian. For better results, use in conjunction with Classic’s Lime Sulfur Dip or Spray.

    Caution:
    For topical and external use only. Avoid contact with eyes and mucous membranes. If eye contact or skin irritation develops, rinse the applied area with water for at least 15 minutes. If ingestion occurs, rinse the mouth with clean water and offer large amounts of fluids. Stop treatment and contact your veterinarian.

    Classic’s Lime Sulfur Cream

    With Aloe and Essential Oils

    For Treatment Of:

    Mange Ringworm Fungus Hot Spots

    Manufactured For: Classic Agrimed LLC

  • PRINCIPAL DISPLAY PANEL

    Lime Sulfur Cream Label

    image description

  • INGREDIENTS AND APPEARANCE
    CLASSIC LIME SULFUR 
    lime sulfur cream
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86130-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM POLYSULFIDE (UNII: 87N1QVL75L) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN, SULFUR - UNII:70FD1KFU70) CALCIUM POLYSULFIDE0.25 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86130-300-0255 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2020
    Labeler - CLASSIC AGRIMED LLC (057659176)
    Registrant - CLASSIC AGRIMED LLC (057659176)
    Establishment
    NameAddressID/FEIBusiness Operations
    CLASSIC AGRIMED LLC057659176manufacture, api manufacture