NDC 63868-955 Quality Choice Anti Itch

Hydrocortisone

NDC Product Code 63868-955

NDC CODE: 63868-955

Proprietary Name: Quality Choice Anti Itch 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

NDC 63868-955-28

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

NDC Product Information

Quality Choice Anti Itch with NDC 63868-955 is a a human over the counter drug product labeled by Chain Drug Marketing Association Inc. The generic name of Quality Choice Anti Itch is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Chain Drug Marketing Association Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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 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.

  • HYDROCORTISONE 1 g/100g

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.

  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • STEARETH-21 (UNII: 53J3F32P58)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • DIMETHICONE 350 (UNII: 2Y53S6ATLU)
  • GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • STEARETH-2 (UNII: V56DFE46J5)

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: 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: 11-07-2019 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: 12-31-2021 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.

Quality Choice Anti Itch Product Label Images

Quality Choice Anti Itch 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

  • Usestemporarily relieves itching associated with minor skin irritation, inflammation, and rashes due to:eczema psoriasisjewelryinsect bitessoapscosmeticsdetergentsseborrheic dermatitispoison ivy, oak, sumactemporarily relieves 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 doctor.for the treatment of diaper rash. Consult a doctor.more than directed unless directed by a doctor

Otc - When Using

  • When using this productavoid contact with eyesdo 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, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctorrectal bleeding occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: ask 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 a soft cloth before applyingapply to affected area not more than 3 to 4 times dailychildren under 12 years of age: ask a doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientsaloe vera leaf, .alpha.-tocopherol acetate, benzyl alcohol, cetyl alcohol, dimethicone 350, edetate disodium, gelatin hydrolysate, glycerin, glyceryl stearate/peg-100 stearate, magnesium ascorbyl, phosphate, matricaria chamomilla, flowering top, menthyl lactate,methyl gluceth-20, methylparaben, petrolatum,polysorbate 60, propylene glycol, propylparaben, purified water, steareth-2, steareth-21, stearyl alcohol, vitamin a palmitate

Dosage & Administration

Distributed by: C.D.M.A., Inc.43157 W 9 Mile Rd.Novi, MI 48375www.qualitychoice.comMade in China

* Please review the disclaimer below.