NDC 71611-025 Wish Ultra Natural Epsom Salt

Magnesium Sulfate

NDC Product Code 71611-025

NDC 71611-025-16

Package Description: 454 g in 1 BAG

NDC Product Information

Wish Ultra Natural Epsom Salt with NDC 71611-025 is a a human over the counter drug product labeled by Click Products Llc. The generic name of Wish Ultra Natural Epsom Salt is magnesium sulfate. The product's dosage form is granule, for solution and is administered via oral form.

Dosage Form: Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.

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.

Wish Ultra Natural Epsom Salt 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.


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)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Click Products Llc
Labeler Code: 71611
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-11-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Wish Ultra Natural Epsom Salt Product Label Images

Wish Ultra Natural Epsom Salt 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

Magnesium Sulfate USP (Epsom Salt)

Purpose

Internal Use.......... Saline LaxativeExternal Use..........Soaking Solution

Warnings - Ask A Doctor Before Use If You Have:

  • Kidney diseasea magnesium restricted dietabdominal pain, nausea or vomitingnoticed a sudden change in bowel habbits that persists over a period of 2 weeksalready used a laxative for a period longer than 1 weekAsk a doctor or pharmacist before use if you are presently taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop And Consult A Doctor If:

  • As Laxative:you have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious conditionyou need to use a laxative for more than 1 weekAs soaking solution:
  • You have redness, irritation, swelling or infection occurshot or warm soaks should not be used by individuals with diabeties except with the advice of a physician

Storage And Handling

Store in cool, dry place out of direct sunlight. Package sold by weight not volume, some settling may occur during shipment. If caking occurs, tap pouch gently to free granules.

* Please review the disclaimer below.