NDC 70105-005 Gopatch Tummyrelief

Calendula Officinalis, Chamomilla, Sepia, Tabacum, Cocculus Indicus, Nux Vomica

NDC Product Code 70105-005

NDC CODE: 70105-005

Proprietary Name: Gopatch Tummyrelief 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: Calendula Officinalis, Chamomilla, Sepia, Tabacum, Cocculus Indicus, Nux Vomica 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.

NDC Code Structure

  • 70105 - Centered Enterprises, Llc

NDC 70105-005-05

Package Description: 5 PATCH in 1 BOX

NDC Product Information

Gopatch Tummyrelief with NDC 70105-005 is a a human over the counter drug product labeled by Centered Enterprises, Llc. The generic name of Gopatch Tummyrelief is calendula officinalis, chamomilla, sepia, tabacum, cocculus indicus, nux vomica. The product's dosage form is patch and is administered via topical form.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Gopatch Tummyrelief 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.

  • POLYVINYL ACETATE (UNII: 32K497ZK2U)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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.

Product Labeler Information

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

Labeler Name: Centered Enterprises, Llc
Labeler Code: 70105
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: 06-10-2021 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.

Gopatch Tummyrelief 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 ingredientsPurpose*Nux Vomica 15C HPUSnausea, indigestion, bloating, gasCocculus Indicus 15C HPUSvomiting, stomach spasms, diarrheaTabacum 6C HPUSstomach pain, belching, nauseaSepia 3C HPUSvomiting after eating, fatigueCalendula Officinalis 3X HPUSsoothes skinChamomilla 3X HPUSgas, bloating, vomiting, diarrheaThe letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Purpose*Nux Vomica 15C HPUS - nausea, indigestion, bloating, gasCocculus Indicus 15C HPUS - vomiting, stomach spasms, diarrheaTabacum 6C HPUS - stomach pain, belching, nauseaSepia 3C HPUS - vomiting after eating, fatigueCalendula Officinalis 3X HPUS - soothes skinChamomilla 3X HPUS - gas, bloating, vomiting, diarrheaThe letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

Uses*Temporarily relieves the symptoms of: ■ nausea ■ minor stomach pain or cramping ■ gas ■ diarrhea ■ stomach upset from excessive eating or drinking ■ heartburn

Warnings

  • WarningsFor external use only.

Do Not Use

Do not use■ on wounds, broken, or irritated skin

■ if you have had reactions to adhesives

Stop Use

Stop use and ask a doctor if fever develops, diarrhea lasts for more than 2 days or worsens, other symptoms persist for more than 3 days.

If Pregnant Or Breast-Feeding

If pregnant or breast-feeding, ask a health professional before use.

Ask Doctor

Ask doctor before use in children under 2 years of age.

Otc - Keep Out Of Reach Of Children

  • Keep out of the reach of children.

Directions

Directions■ GoPatch must completely cover the navel.

■ Skin around navel must be clean, dry and free of lotions.

■ Remove GoPatch from sheet and apply completely covering navel.

■ Remove GoPatch
no more than 12 hours after application.

■ Repeat as necessary.

Other Safety Information

  • Other informationStore out of direct sunlight, in dry place, at 65-80°F (20-25°C).Contains no known allergens, free of latex, corn, soy, wheat, and yeast.If unsatisfied with GoPatch, please email us at [email protected] for full money back guarantee.

Inactive Ingredient

Inactive ingredients Acrylic adhesive

Questions?

Questions or comments? Please call us at (707) 733-3011 or www.TheGoPatch.com

* Please review the disclaimer below.