NDC 81335-532 Zcort Ultra

Hydrocortisone Acetate 1%

NDC Product Code 81335-532

NDC 81335-532-15

Package Description: 15 g in 1 BOX

NDC Product Information

Zcort Ultra with NDC 81335-532 is a a human over the counter drug product labeled by Rxdino, Llc. The generic name of Zcort Ultra is hydrocortisone acetate 1%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rxdino, Llc

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.

Zcort Ultra 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 ACETATE 10 mg/g

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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PRASTERONE (UNII: 459AG36T1B)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • JOJOBA OIL (UNII: 724GKU717M)
  • WATER (UNII: 059QF0KO0R)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

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: Rxdino, Llc
Labeler Code: 81335
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: 03-01-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Zcort Ultra 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

Drug Facts Active Ingredients

Hydrocortisone Acetate 1%

Purpose

Anti-Itch

Uses

  • Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:Eczemapsoriasis poison ivy, oak, sumacinsect bitesdetergentsjewelrycosmeticssoapsseborrheic dermatitistemporarily relieves external anal and genital itchingother uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • For the treatment of diaper rashif pregnant or nursing - consult a doctorin the genital area if you have a vaginal discharge - consult a doctor

When Using This Product

  • Avoid contact with 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

Stop Use And Ask A Doctor

  • If condition worsens or persists for more than 7 daysif condition clears up and occurs againif rectal bleeding occursbefore using any other hydrocortisone product

Keep Out Of Reach Of Children

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

Directions

  • FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHESadults and children 12 years of age and older apply to affected area not more than 2 to 3 times dailyFOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTSwhen 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 2 to 3 times dailyAges 12 to 18 years: ask a doctor

Other Information

Contents filled by weight, not volume

Inactive Ingredients

Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum

Front Display Panel And Back Card

  • NEW!FORMULATED TO HEAL ITCH AND PROTECT COLLAGENSTEROID POWERFAST ACTING RashPoison IvyEczemaInsect BitesPsoriasisInflammationUNIQUE PATENTED FORMULAZCort ULTRA+ ANTI-ITCH CREAMNET WT 0.5 OZ (15g)ACTIVE INGREDIENT: HYDROCORTIZONE 1% WITH DHEAsee zcortfront.jpgZCort Ultra+ ANTI-ITCH CREAM BACK CARDsee zcortbackbox.jpg

* Please review the disclaimer below.