PHUEL SPRAY

PHUEL SPRAY

Drug Labeling and Warnings

Drug Details

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PHUEL- magnesium sulfate heptahydrate spray 
Avadim Technologies, Inc

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.

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PHUEL SPRAY

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

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 Technologies, Inc (041443877)
Registrant - Avadim Technologies, Inc (041443877)
Establishment
NameAddressID/FEIBusiness Operations
Avadim Technologies, Inc041443877manufacture(61594-011)

Revised: 2/2019
 
Avadim Technologies, Inc


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