FDA.reportPublic FDA data

PHUEL SPRAY

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2023-04-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:21:01

Label at a glance#

ProductPHUEL
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure6 sections

Indications and uses

activate muscle function release muscle tightness reduce muscle soreness

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Muscle Soreness Relief

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

unintended effects occur.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-011-07PHUEL210 mL in 1 BOTTLE, PLASTICSPRAY2106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-011PHUEL (MAGNESIUM SULFATE HEPTAHYDRATE) SPRAY [AVADIM HOLDINGS, INC.]6Current NDC, Legacy NDC, 1 package rows20230426_f5c012a3-52ad-40fe-aa02-e26efc23c81f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-01161594-011-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILVER3M4G523W1GIACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
GRAPEFRUITO82C39RR8CIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
EDETATE SODIUMMP1J8420LUIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHUELMAGNESIUM SULFATE HEPTAHYDRATEAVADIM HOLDINGS, INC.f5c012a3-52ad-40fe-aa02-e26efc23c81f2023-04-25WarningsExact identifier
ndc (package): 61594-011-07
ndc (product): 61594-011
ndc11 (package): 61594001107
spl id: fa232638-86cb-780a-e053-6394a90a30a2
spl set id: f5c012a3-52ad-40fe-aa02-e26efc23c81f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.