NDC 69396-082 Hemorrhoidalointment

Mineral Oil, Petrolatum, Phenylephrine Hci

NDC Product Code 69396-082

NDC 69396-082-02

Package Description: 1 TUBE in 1 BOX > 57 g in 1 TUBE

NDC Product Information

Hemorrhoidalointment with NDC 69396-082 is a a human over the counter drug product labeled by Trifecta Pharmaceuticals Usa Llc. The generic name of Hemorrhoidalointment is mineral oil, petrolatum, phenylephrine hci. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1372298.

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.

Hemorrhoidalointment 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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • LAURETH-23 (UNII: N72LMW566G)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-18-2021 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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Hemorrhoidalointment Product Label Images

Hemorrhoidalointment 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

Phenylephrine HCI 0.25%

Mineral Oil 14%

Petrolatum 74.9%

Purpose

Vasoconstrictor

Protectant

Protectant

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoidsTemporarily shrinks hemorrhoidal tissue and relieves burningTemporarily provides a coating for relief of anorectal discomfortsTemporarily profects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

  • For external and/or intrarectal use onlyAsk doctor before use if you haveheart diseasehigh blood pressurethyroid diseasediabetesdifficulty urinating due to an enlarged prostate glandAsk doctor before use if you are presently taking a prescription drug for high blood pressure or depression

Stop Use And Ask Doctor If

  • Bleeding occursCondition worsens or does not improve within 7 daysIntroduction of applicator into the rectum causes additional pain

If Pregnant Or Breast-Feeding

Ask a doctor before use

Keep Out Of Reach Of Children

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

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 with a soft cloth before applying ointmentApply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementIntrarectal Use: Remove cover from applicator, attach applicator to tube, lubricate applicator well, and gently insert applicator into rectum. thoroughly cleanse applicator after each use and replace cover.Also apply ointment to external areaRegular use provides continual therapy for relief of symptomsChildren under 12 years of age: ask a doctor

Other Information

  • Store at room temperature 20°-25°C (68°-77°F)Questions? Call 1-888-296-9067

Distributed By

CVS Pharmacy Inc.One CVS DriveWoonsocket, RI 02895©2020 CVS PharmacyCVS.com1-800-SHOP CVSMade in ChinaV-36582CVS Quality Money Back guaranteeThis product is not manufactured or distributed by Wyeth LLC, owner of registered trademark Preparation H®

Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

* Please review the disclaimer below.