NDC 58354-112 Chi Kung Huo Shiueh Kao

Menthol, Zinc Oxide

NDC Product Code 58354-112

NDC 58354-112-02

Package Description: 6 PATCH in 1 POUCH > 235 mg in 1 PATCH (58354-112-01)

NDC Product Information

Chi Kung Huo Shiueh Kao with NDC 58354-112 is a a human over the counter drug product labeled by Cho-a Pharm.co.,ltd.. The generic name of Chi Kung Huo Shiueh Kao is menthol, zinc oxide. The product's dosage form is patch and is administered via topical form.

Labeler Name: Cho-a Pharm.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.

Chi Kung Huo Shiueh Kao 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.

  • MENTHOL 40 mg/235mg
  • ZINC OXIDE 50 mg/235mg

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.

  • RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)

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: Cho-a Pharm.co.,ltd.
Labeler Code: 58354
FDA Application Number: part348 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: 02-25-2019 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: 12-31-2020 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.

Chi Kung Huo Shiueh Kao Product Label Images

Chi Kung Huo Shiueh Kao 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

Menthol 40 mgZinc Oxide 50 mg

Purpose

External AnalgesicExternal Analgesic

Keep Out Of Reach Of Children

• In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

ArthritisSimple backacheStrainsBruisesSprains

Warnings

  • For external use onlyDo not useon wounds or damaged skinif you are allergic to any ingredients of this productwith a heating padwith, or at the same time as, other externalanalgesic productsWhen using this productdo not use otherwise than directedavoid contact with eyes, mucous membranes or rashesdo not bandage tightlyAsk a doctor before use if you are prone to allergic reaction from aspirin or salicylateStop use and ask a doctor ifrash, itching, or excessive skin irritation developsconditions worsensymptoms persist for more than 7 dayssymptoms clear up and occur again within a few days

Directions

  • Adults and children 12 years of age and over:Clean and dry affected areaRemove patch from filmApply 1 patch at a time to affected area, no more than 3 to 4 times daily for 7 daysRemove patch from skin after at most 8 hours applicationChildren under 12 years of age: consult a doctor

Inactive Ingredients

Clematis Radix, Salicylic Acid Methyl, Myrrha, Ricini Semen, Momordicae Semen, Olibanum

* Please review the disclaimer below.

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