NDC 57520-0595 Water X

Betula Pendula, Cortex, Lappa Major, Plantago Major, Taraxacum Officinale,

NDC Product Code 57520-0595

NDC Code: 57520-0595

Proprietary Name: Water X What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Betula Pendula, Cortex, Lappa Major, Plantago Major, Taraxacum Officinale, What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
NONE
Score: 1

NDC Code Structure

  • 57520 - Apotheca Company
    • 57520-0595 - Water

NDC 57520-0595-1

Package Description: 30 g in 1 BOTTLE

NDC Product Information

Water X with NDC 57520-0595 is a a human over the counter drug product labeled by Apotheca Company. The generic name of Water X is betula pendula, cortex, lappa major, plantago major, taraxacum officinale,. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Apotheca Company

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Water X 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.

  • BETULA PENDULA BARK 4 [hp_X]/g
  • ARCTIUM LAPPA ROOT 4 [hp_X]/g
  • PLANTAGO MAJOR 4 [hp_X]/g
  • TARAXACUM OFFICINALE 4 [hp_X]/g

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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
  • AGATHOSMA BETULINA LEAF (UNII: 369DDH39Z0)
  • ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W)
  • JUNIPERUS COMMUNIS FRUIT (UNII: O84B5194RL)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)

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: Apotheca Company
Labeler Code: 57520
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: 01-25-2011 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: 12-31-2018 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: E 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.

Water X Product Label Images

Water X 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

Otc - Active Ingredient

ACTIVE INGREDIENTS:  Betula pendula, cortex 4X, Lappa major 4X, Plantago major 4X, Taraxacum officinale 4X.

Otc - Purpose

USES:  For fast temporary relief of water retention.  Results are usually felt within hours or days, and increase with longer use.

Warnings

WARNINGS:  Stop use and ask a doctor if symptoms continue or get worse, or if new symptoms occur.  If pregnant or nursing ask a doctor before use.Keep out of reach of children.

Dosage & Administration

DIRECTIONS:  Adults and children 12 or over take 2 capsules every 4-8 hours as needed.  Once desired results are obtained try 1-2 capsules twice daily for maintenance.  May be used indefinitely if desired, or as needed for seasonal or temporary conditions.

Inactive Ingredient

OTHER INGREDIENTS:  Birch leaf. Burdock root, Dandelion root, Buchu leaf, Couch grass rhizome, Juniper berry, Microcrystalline cellulose, cellulose capsule.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Indications & Usage

USES:  For fast temporary relief of water retention.  Results are usually felt within hours or days, and increase with longer use.

Otc - Questions

Manufactured for:RidgeCrest Herbals, Inc.3683 West 2270 South, Suite ASalt Lake City, UT 84120-2306www.ridgecrestherbals.com1-800-242-4649

* Please review the disclaimer below.

Previous Code
57520-0584
Next Code
57520-0596