FDA.reportPublic FDA data

CVS Spray

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:09:33

Label at a glance#

ProductCVS
Active ingredientMAGNESIUM SULFATE, UNSPECIFIED FORM
Label structure6 sections

Indications and uses

prevents cramps and spasms releases muscle tightness  relieves muscle soreness

Dosage and administration

shake well  apply 6-8 pumps on each impacted muscle group  rub in briskly until absorbed  repeat allow to air dry use as needed

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

  • prevents cramps and spasms
  • releases muscle tightness 
  • relieves 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°F and 120°F
  • 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 on each impacted muscle group 
  • rub in briskly until absorbed 
  • repeat allow to air dry
  • use as needed

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-01261594-012-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILVER3M4G523W1GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
GRAPEFRUITO82C39RR8CIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
EDETATE SODIUMMP1J8420LUIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABACTIB

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
d7340703-72b0-f09f-e053-2a95a90aa5d9a1260738-ad84-0ddb-e053-2995a90a02ac2022-02-04WarningsExact identifier
spl id: d7340703-72b0-f09f-e053-2a95a90aa5d9
spl set id: a1260738-ad84-0ddb-e053-2995a90a02ac

Reported adverse events (FAERS/openFDA)#

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