NDC 63868-597 Quality Choice Anti Itch With Aloe

Product Information

What is NDC 63868-597?

The NDC code 63868-597 is assigned by the FDA to the UNFINISHED product Quality Choice Anti Itch With Aloe which is product labeled by Chain Drug Marketing Association Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 63868-597-28 1 tube in 1 carton / 28 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63868-597
Proprietary Name 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.		Quality Choice Anti Itch With Aloe
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Chain Drug Marketing Association Inc
Labeler Code63868
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-15-2015
Listing Expiration Date 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.		12-31-2021
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		I
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Quality Choice Anti Itch With Aloe?


Product Packages

NDC Code 63868-597-28

Package Description: 1 TUBE in 1 CARTON / 28 g in 1 TUBE

Price per Unit: $0.05691 per GM

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

Quality Choice Anti Itch With Aloe Active Ingredients UNII Codes

Quality Choice Anti Itch With Aloe Inactive Ingredients UNII Codes

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.

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Patient Education

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]

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Quality Choice Anti Itch With Aloe Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Otc - Active Ingredient



Active ingredient                                                         Purpose

Hydrocortisone 1%................................................... Anti-itch


Otc - Purpose



Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
  • for temporary relief of external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor
  • for the treatment of diaper rash. Consult a doctor

Otc - When Using



When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • rectal bleeding occurs


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.


Indications & Usage



Directions

  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Storage And Handling



Other information

  • store at 20°-25°C (68°-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

aloe vera gel, butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetyether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol


Dosage & Administration



DISTRIBUTED BY C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA


* Please review the disclaimer below.