NDC 72850-0004 Stozyme

Pancreatin, Hemicellulase, Ox Bile Extract, Dimethicone

NDC Product Code 72850-0004

NDC CODE: 72850-0004

Proprietary Name: Stozyme 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: Pancreatin, Hemicellulase, Ox Bile Extract, Dimethicone 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Product Characteristics

Color(s):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
15 MM
Score: 1

NDC Code Structure

  • 72850 - Chunwoo Pharmaceutical Co., Ltd.

NDC 72850-0004-1

Package Description: 10 TABLET in 1 BLISTER PACK

NDC Product Information

Stozyme with NDC 72850-0004 is a a human over the counter drug product labeled by Chunwoo Pharmaceutical Co., Ltd.. The generic name of Stozyme is pancreatin, hemicellulase, ox bile extract, dimethicone. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Stozyme 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.

  • HEMICELLULASE (ASPERGILLUS NIGER) 10.42 1/1001
  • DIMETHICONE 5.21 1/1001
  • PANCRELIPASE 36.46 1/1001
  • BOS TAURUS BILE 5.21 1/1001

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.

  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

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.
  • 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: Chunwoo Pharmaceutical Co., Ltd.
Labeler Code: 72850
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: 10-19-2019 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’.

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Stozyme Product Label Images

Stozyme 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

Pancreatin 36.46%Hemicellulase 10.42%Ox Bile Extract 5.21%Dimethicone 5.21%

Inactive Ingredient

Food Blue No. 1, Food Yellow No. 4, Colloidal Silicon Dioxide, Microcrystalline Cellulose, Low-Substituted Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose Phthalate, Glyceryl Monostearate, Castor Oil, Hypromellose 2910, Titanium Oxide, Polyethylene Glycol 6000,

Purpose

Anorexia, overeating, and abdominal distention

Keep Out Of Reach Of Children

Keep out of reach of children.

Warning

Do not take if-you have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medicine contains lactose (sugar) carbohydrates.-you are under 5Ask doctor before taking if- you are on other medication- you are hypersensitive or have history of allergic response to TartazineKeep the proper usage and volumeStop use and ask a doctor if- If there is no improvement in the irradiation after 2 weeks of taking the medicine

Uses

For oral use only

Indication & Usage Section

Treats anorexia, overeating, and abdominal distention

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