NDC 70837-001 Foot Detox

Zinc Oxide

NDC Product Code 70837-001

NDC Product Information

Foot Detox with NDC 70837-001 is a a human over the counter drug product labeled by Sichuan Fragrant Plant Biotechnology Co, Ltd. The generic name of Foot Detox is zinc oxide. The product's dosage form is patch and is administered via topical form.

Labeler Name: Sichuan Fragrant Plant Biotechnology Co, Ltd

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.

Foot Detox 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.

  • ZINC OXIDE 8.3 g/100g

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.

  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)
  • SHRIMP SHELL CHITIN (UNII: 8SH93A7QWW)
  • SCHORL TOURMALINE (UNII: 173O8XLY6T)
  • POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
  • PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
  • SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)
  • HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
  • GYNOSTEMMA PENTAPHYLLUM LEAF (UNII: 5DWS84R85M)

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: Sichuan Fragrant Plant Biotechnology Co, Ltd
Labeler Code: 70837
FDA Application Number: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-09-2016 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 - 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.

Foot Detox Product Label Images

Foot Detox 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 Ingredients

Zinc Oxide    8.3%

Purpose

Zinc Oxide                 Skin Protectant

Directions

Adults, and children 12 years of age and over, clean and dry up the area for the patch to be attached. Remove the protective cover sheet and gently apply. Leave it on at least 4 hours before removal. Children under 12 years of age, consult a doctor.

When Using The Product

Do not use otherwise than directed.Do not stretch out the adhesive tape.Do not take out the contents from the patch.If patch is damaged, discard it right away.

Warning

For External Use Only.

Do Not Use

On wounds, damaged skin or face.If you are allergic to any ingredients of the product.With other external product at the same time.

Stop Use And Ask A Doctor

If allergic reaction or irritation occurs.If you are pregnant, nursing or under medical treatment.

Storage

Store in a dry and cool place away from direct sunlight.

Manufactured By

Sichuan Fragrant Plant Biotechnology Co, LtdShigao Industrial Park, Tianfu New District, Xinjia Village, Shigao Town, Renshou County, Chengdu, Sichuan, China 610020Phone: 86-28-83503710

Inactive Ingredients

FERRIC OXIDE RED, APPLE CIDER VINEGAR, SHRIMP SHELL CHITIN, SCHORL TOURMALINE, POLYETHYLENE GLYCOL 200, PANAX NOTOGINSENG ROOT, SALVIA MILTIORRHIZA ROOT, HIPPOPHAE RHAMNOIDES FRUIT, GYNOSTEMMA PENTAPHYLLUM LEAF

* Please review the disclaimer below.