Label: CALENDULA SP liquid

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

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Drug Label Information

Updated November 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Ingredients: Calendula Oil, Lime Sulfur Concentrate, Aloe Vera, Lavender Oil, Fragrance, Glycerin, Soothing Lotion Base

    Directions For Use: Shake well before use. Hold spray 4 to 6 inches away and apply directly to affected area. Spray affected areas 2 to 3 times daily or as directed by veterinarian.

    Do not use in areas if pus is present. For short term use only. After using the product as directed, if conditions does not improve in 7 to 10 days, consult your veterinarian. Not for prolonged use.

    Store at room temperature.

    Read entire label before each use. Use only in accordance with labeled instructions. 

    Caution:

    Keep out of reach of children.
    For animal and topical use only. Do not spray in the face, eyes, genitals or mucous membranes. Do not allow pet to ingest. If irritation, redness, inflammations or swelling develops or persists, discontinue use immediately and consult your veterinarian.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CALENDULA SP 
    calendula sp liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86130-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) (CALENDULA OFFICINALIS SEED OIL - UNII:9JS8DS42SV) CALENDULA OFFICINALIS SEED OIL1 g  in 100 mL
    CALCIUM POLYSULFIDE (UNII: 87N1QVL75L) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN, SULFUR - UNII:70FD1KFU70) CALCIUM POLYSULFIDE0.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86130-201-04118 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/23/2023
    Labeler - CLASSIC AGRIMED LLC (057659176)
    Registrant - CLASSIC AGRIMED LLC (057659176)
    Establishment
    NameAddressID/FEIBusiness Operations
    CLASSIC AGRIMED LLC057659176manufacture, api manufacture
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