NDC 76614-100 Jikimi Patch

Anti-bacterial Patch

NDC Product Code 76614-100

NDC 76614-100-10

Package Description: 4 PATCH in 1 PACKAGE

NDC Product Information

Jikimi Patch with NDC 76614-100 is a a human over the counter drug product labeled by Bm Pharmaceutical Co., Ltd.. The generic name of Jikimi Patch is anti-bacterial patch. The product's dosage form is patch and is administered via topical form.

Labeler Name: Bm Pharmaceutical 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.

Jikimi Patch 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.

  • LEVOMENTHOL .03 1/1
  • ALCOHOL .07 1/1
  • EUCALYPTUS OIL .2 1/1

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.

  • FENUGREEK SEED OIL (UNII: 50LM4E7MG3)
  • POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
  • THYME OIL (UNII: 2UK410MY6B)

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: Bm Pharmaceutical Co., Ltd.
Labeler Code: 76614
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-01-2020 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.

Jikimi Patch 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(S)

Ethyl alcohol 7% w/w………………………...………. AntimicrobialLevomenthol 3% w/w………………………...………. AntifungalEucalyptus oil 20% w/w…………………………...…. Antimicrobial

Purpose

To help reduce bacteria.

Use

Apply to affected area as topical aromatic diffusion.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • Do not use if you are allergic to any ingredients of this product.Do not use in children under 6 and pregnant or breast-feeding.

Otc - When Using

When using this product use only as directed. Use within 2 days after removing the film. Avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts. It happen headache. Conditions worsen.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Remove patch from film.

Apply to affected area as topical aromatic diffusion not more than 3 to 4 times daily.
Remove patch at most 24-36 hours application.

Other Information

  • Store at room temperature between 1-30oC (33.8-86oF).Avoid storing product in direct sunlight.Protect product from excessive moisture.

Inactive Ingredients

Extract of fenugreek, Patchouli oil, Thyme oil.

* Please review the disclaimer below.