Label: SORE THROAT 911- potassium chloride lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 22, 2023

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  • DOSAGE & ADMINISTRATION

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  • WARNINGS

    warnings

  • INACTIVE INGREDIENT

    inactive list

  • KEEP OUT OF REACH OF CHILDREN

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  • ACTIVE INGREDIENT

    OTC-Active ingredients

  • PURPOSE

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  • INDICATIONS & USAGE

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SORE THROAT 911 
    potassium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35484-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CATION (UNII: 295O53K152) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION0.05 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    UREA (UNII: 8W8T17847W)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35484-204-211 in 1 CARTON03/09/2020
    121 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/09/2020
    Labeler - DelCorean, LLC (831347104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc793406000manufacture(35484-204)