NDC 61594-012 Cvs

Magnesium Sulfate, Unspecified Form

NDC Product Code 61594-012

NDC 61594-012-07

Package Description: 210 mL in 1 BOTTLE

NDC Product Information

Cvs with NDC 61594-012 is a a human over the counter drug product labeled by Avadim Health, Inc.. The generic name of Cvs is magnesium sulfate, unspecified form. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Avadim Health, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cvs Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM SULFATE, UNSPECIFIED FORM 6 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SILVER (UNII: 3M4G523W1G)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avadim Health, Inc.
Labeler Code: 61594
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-31-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cvs Product Label Images

Cvs Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Contains Magnesium Sulfate (Magnesia sulphurica 6X 0.05% HPUSThe 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*

  • Prevents cramps and spasms releases muscle tightness relieves muscle soreness

Warnings

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

When Using This Product

  • Avoid eye contactstore between 32°F and 120°Fuse only as directednot 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 on each impacted muscle group rub in briskly until absorbed repeat allow to air dryuse as needed

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)

* Please review the disclaimer below.