NDC 73513-323 Topwin Speedy Enema

Glycerin

NDC Product Code 73513-323

NDC CODE: 73513-323

Proprietary Name: Topwin Speedy Enema 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: Glycerin 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 product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 73513 - Health Chemical Pharmaceutical Co., Ltd

NDC 73513-323-20

Package Description: 5 PACKET in 1 BOX > 2 APPLICATOR in 1 PACKET > 20 mL in 1 APPLICATOR

NDC Product Information

Topwin Speedy Enema with NDC 73513-323 is a a human over the counter drug product labeled by Health Chemical Pharmaceutical Co., Ltd. The generic name of Topwin Speedy Enema is glycerin. The product's dosage form is enema and is administered via rectal form.

Labeler Name: Health Chemical Pharmaceutical Co., Ltd

Dosage Form: Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.

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.

Topwin Speedy Enema 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.

  • GLYCERIN 3 g/100mL

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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.

Product Labeler Information

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

Labeler Name: Health Chemical Pharmaceutical Co., Ltd
Labeler Code: 73513
FDA Application Number: part334 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: 05-28-2020 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.

Topwin Speedy Enema Product Label Images

Topwin Speedy Enema 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

Glycerin  3g

Purpose

Glycerin     Hyperosmotic Laxative

Uses

For relief of occasional constipation

Warnings

For rectal use only

Do Not Use

When rectal irritation, abdominal pain, nausea, fever, or vomiting are present unless directed by a doctor.

Ask A Doctor Before Using Any Laxative If You Have

  • A sudden change in bowel habits lasting more than 2 weeksalready used a laxative for more than 1 week

Stop Using And Ask A Doctor If You Have

  • Rectal discomfort burning sensationrectal bleedingno bowel movement within 1 hour of using this product

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Single Daily Usage (per 24 hours)Adults and children, 6 years and over: 20 ml / 3g Glycerin or as directed by a doctorChildren 3-6 years: 10 ml / 1.5g Glycerin or as directed by a doctorKnee-chest / Upright position: Lubricate anus with petroleum jelly first, gently insert tip of the enema applicator into the rectum with a single side to side movement to prevent damage to the rectal wall, allow 15 minutes to 1 hour to produce bowel movement. Discard unit after use. No left fluid should be re-used.

Other Information

Store below 77°F (25 °C) in a cool dry place and protected from sunlight. Do not use if cap is broken.

Inactive Ingredients

Methylparaben, Sodium Chloride, Sodium Benzoate, Water

Questions?

Manufactured by Health Chemical Pharmaceutical Co, LtdMade in TaiwanU.S. Importer: Larkin Inc. dba Asia Company1695 Jerrold Avenue, San Francisco, CA 94124Email: info@larkinin-us.comPhone: (415)285-8888

* Please review the disclaimer below.