Label: UMCKA COLDCARE LEMON- pelargonium sidoides powder

  • 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 February 24, 2023

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  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE LEMON 
    pelargonium sidoides powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83102-5146
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TURMERIC (UNII: 856YO1Z64F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Natural Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83102-5146-010 in 1 CARTON02/24/2023
    15 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2023
    Labeler - ProSolutions, Inc. (070769782)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProSolutions, Inc.070769782label(83102-5146) , pack(83102-5146)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(83102-5146)
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