NDC 58354-118 Cho-a Care Lot 1%

Glyceryl Stearate, Hydrocortisone

NDC Product Code 58354-118

NDC CODE: 58354-118

Proprietary Name: Cho-a Care Lot 1% 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: Glyceryl Stearate, Hydrocortisone 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 to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

NDC Code Structure

  • 58354 - Cho-a Pharm.co.,ltd.

NDC 58354-118-02

Package Description: 1 TUBE in 1 BOX > 50 g in 1 TUBE (58354-118-01)

NDC Product Information

Cho-a Care Lot 1% with NDC 58354-118 is a a human over the counter drug product labeled by Cho-a Pharm.co.,ltd.. The generic name of Cho-a Care Lot 1% is glyceryl stearate, hydrocortisone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cho-a Pharm.co.,ltd.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Cho-a Care Lot 1% 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.

  • GLYCERYL MONOSTEARATE 10 mg/50g
  • HYDROCORTISONE 10 mg/50g

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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • DIMETHICONE (UNII: 92RU3N3Y1O)

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: 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: 10-25-2019 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.

Cho-a Care Lot 1% 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

Glyceryl Stearate 10mg Hydrocortisone10mg

Purpose

Insect BitesAnti-itch

Keep Out Of Reach Of Children

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

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes.Other uses of this product should only be under the advice and supervision of a doctor

Warnings

WarningsFor external use only.Ask a doctor if condition worsens, deep puncture wounds, animal bites, or serious burns.Stop use and ask a doctor if the condition worsens, or if symptoms persist for more than 7days or clear up and occur again within a few days.Do not begin to use any other hydrocortisone product unless you have consulted a doctor.If Pregnant or breast-feeding, ask a health professional before use.

Directions

Shake well before use.Adults and children 2 years of age and older: apply to the affected area 1 to 3 times daily.

Inactive Ingredients

Butylene glycol, Caprlic and capric triglyceride, Carbomer 940, Carbomer 941, Cetanol, Concentrated glycerin, Dimethicone, Glyceryl stearate SE, Lanoline, Stearic acid, Liquid paraffin, Propylene glycol, Prolysorbate 60, PVP eicosyne copolymer, Sorbitan stearate.

* Please review the disclaimer below.