Label: PHUEL- magnesium sulfate heptahydrate spray

  • 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 April 25, 2023

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  • Drug Facts

  • Active Ingredient

    Contains Magnesium Sulfate (Magnesia sulphurica 6X 0.05% HPUS

    The letters H.P.U,S, indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    Purpose

    Muscle Soreness Relief

  • Uses

    • activate muscle function
    • release muscle tightness
    • reduce muscle soreness
  • Warnings

    For external use only. If eye contact occurs, rinse thoroughly with water.

    When using this product

    • avoid eye contact
    • store between 32° and 120° Fahrenheit
    • use only as directed
    • not for ingestion

    Stop use and ask a doctor if

    unintended effects occur.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • apply 6-8 pumps onto desired muscle group(s) or area
    • rub in briskly until absorbed
    • repeat
    • use as desired
    • allow to air dry
  • Inactive Ingredients

    Aqua (Water), Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Colloidal Silver, Tocopheryl Acetate, Glycerin, Allantoin, Beta Glucan, Citrus Paradisi (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone, Methylparaben, Propylparaben, Parfum (Fragrance)

  • Package Labeling: (61594-011-07)

    Label3

  • INGREDIENTS AND APPEARANCE
    PHUEL 
    magnesium sulfate heptahydrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-011
    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
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILVER (UNII: 3M4G523W1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-011-07210 mL in 1 BOTTLE, PLASTIC; 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 - AVADIM HOLDINGS, INC. (118512488)
    Registrant - AVADIM HOLDINGS, INC. (118512488)
    Establishment
    NameAddressID/FEIBusiness Operations
    AVADIM HOLDINGS, INC.118512488manufacture(61594-011)
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