NDC 63868-597 Quality Choice Anti Itch With Aloe

Hydrocortisone

NDC Product Code 63868-597

NDC CODE: 63868-597

Proprietary Name: Quality Choice Anti Itch With Aloe 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: 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

  • 63868 - Chain Drug Marketing Association Inc
    • 63868-597 - Quality Choice Anti Itch With Aloe

NDC 63868-597-28

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

Price per Unit: $0.05780 per GM

NDC Product Information

Quality Choice Anti Itch With Aloe with NDC 63868-597 is a a human over the counter drug product labeled by Chain Drug Marketing Association Inc. The generic name of Quality Choice Anti Itch With Aloe is hydrocortisone. The product's dosage form is ointment and is administered via topical form.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Quality Choice Anti Itch With Aloe 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: Chain Drug Marketing Association Inc
Labeler Code: 63868
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: 01-15-2015 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 - NO 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".

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Information for Patients

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 Images

Quality Choice Anti Itch With Aloe 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

Otc - Active Ingredient

Active ingredient                                                         PurposeHydrocortisone 1%................................................... Anti-itch

Otc - Purpose

  • Usesfor 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 psoriasisfor temporary relief of external anal and genital itchingother uses of this product should only be under the advice and supervision of a doctor

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not usein the genital area if you have a vaginal discharge. Consult a doctorfor the treatment of diaper rash. Consult a doctor

Otc - When Using

  • When using this productavoid contact with the eyesdo not use more than directed unless told to do so by a doctordo not put directly into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

  • Stop use and ask a doctor ifcondition 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 doctorrectal bleeding occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Directionsfor 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 dailychildren under 2 years of age: consult a doctorfor external anal and genital itching, adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or soft cloth before applyingapply to affected area not more than 3 to 4 times dailychildren under 12 years of age: consult a doctor

Storage And Handling

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

Inactive Ingredient

Inactive ingredientsaloe 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 MILENOVI, MI 48376-0995www.qualitychoice.comMADE IN KOREA

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