PHUEL- magnesium sulfate heptahydrate spray

PHUEL by

Drug Labeling and Warnings

PHUEL by is a Homeopathic medication manufactured, distributed, or labeled by AVADIM HOLDINGS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

PHUEL 
magnesium sulfate heptahydrate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-011-07	210 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/07/2018

Labeler - Avadim Health, Inc. (041443877)

Registrant - Avadim Health, Inc. (041443877)

Establishment
Name	Address	ID/FEI	Business Operations
Avadim Health, Inc.		041443877	manufacture(61594-011)