Label: PHUEL- magnesium sulfate heptahydrate solution

  • Category: HUMAN PRESCRIPTION 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 April 26, 2021

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  • INGREDIENTS AND APPEARANCE
    PHUEL 
    magnesium sulfate heptahydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71064-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71064-0010-7210 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2018
    2NDC:71064-0010-3101 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/07/2018
    Labeler - Relion Manufacturing (085629765)
    Registrant - Avadim Technologies Inc. (041443877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Relion Manufacturing085629765manufacture(71064-0010)