NDC 69396-081 Hydrocortisone 1%

Hydrocortisone

NDC Product Code 69396-081

NDC CODE: 69396-081

Proprietary Name: Hydrocortisone 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: 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 69396 - Trifecta Pharmaceuticals Usa Llc

NDC 69396-081-01

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

NDC Product Information

Hydrocortisone 1% with NDC 69396-081 is a a human over the counter drug product labeled by Trifecta Pharmaceuticals Usa Llc. The generic name of Hydrocortisone 1% is hydrocortisone. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 106258.

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.

Hydrocortisone 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.


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.

  • GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)

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: Trifecta Pharmaceuticals Usa Llc
Labeler Code: 69396
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: 06-23-2021 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".

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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 topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticos...
[Read More]
Steroids

Steroids is

...
[Read More]

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Hydrocortisone 1% Product Label Images

Hydrocortisone 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 Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

Temporary relieves external anal itching.temporary relief of itching associated with minor skin irritations and rashesother uses of this product should be only under the advice and supervision of a doctor

When Using This Product

Avoid Contact with eyesdo not exceed the recommended daily dosage unless directed by a doctordo not put into the rectum by using fingers or any mechanical device or applicator

Warnings

For external use only

Directions

●Adults when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. ●gently dry by patting or blotting with a tissue or soft cloth before application of this product.●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.●children under 12 years of age: do not use, consult a doctor.

Inactive Ingredients

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

Other Information

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Distributed by:CVS Pharmacy, Inc.One CVS DriveWoonsocket, RI 02895© 2020 CVS PharmacyCVS.com1 800 Shop CVSMade in ChinaV-36582This product is not manufactured or distributed by Pfizer, distributor of Preparation H Anti-itch Cream.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)

Stop Use And Ask A Doctor If

Bleeding occurscondition worsenssymptoms 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.

Do Not Use

Do not use for the treatment of Diaper Rash. Consult Doctor.

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