NDC 69396-033 Hemorrhoidal Cream

Glycerol, Phenylephine, Pramoxine, Petrolatum

NDC Product Code 69396-033

NDC Code: 69396-033

Proprietary Name: Hemorrhoidal Cream Additional informationCallout TooltipWhat 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: Glycerol, Phenylephine, Pramoxine, Petrolatum Additional informationCallout TooltipWhat 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.


Code Structure
  • 69396 - Trifecta Pharmaceuticals Usa Llc
    • 69396-033 - Hemorrhoidal Cream

NDC 69396-033-18

Package Description: 1 TUBE in 1 BOX > 51 g in 1 TUBE

NDC Product Information

Hemorrhoidal Cream with NDC 69396-033 is a a human over the counter drug product labeled by Trifecta Pharmaceuticals Usa Llc. The generic name of Hemorrhoidal Cream is glycerol, phenylephine, pramoxine, petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Trifecta Pharmaceuticals Usa 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 Additional informationCallout TooltipWhat 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.


Hemorrhoidal Cream Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENYLEPHRINE HYDROCHLORIDE .25 g/100g
  • PRAMOXINE HYDROCHLORIDE 1 g/100g
  • PETROLATUM 15 g/100g
  • GLYCERIN 14.4 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-25-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Hemorrhoidal Cream Product Label Images

Hemorrhoidal Cream 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

Glycerol 14.4%

Phenylephrine HCI 0.25%

Pramoxine HCI 1%

Petrolatum 15%

Purpose

Protectant

Vasoconstrictor

Local Anesthetic

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 protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Stop Use And Ask A Doctor

Bleeding occursCondition worsens or does not improve within 7 daysAn allergic reaction developsThe symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If Pregnant Or Breast Feeding

Ask doctor before use

Keep Out Of Reach Of Children

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

Directions

Adults:When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.When first opening tube, puncture foil seal with top end of capApply externally or in the lower portion of the anal canal onlyApply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Warnings

For External Use OnlyAsk doctor brfore use if you haveHeart DiseaseThyroid DiseaseDiabetesTrouble urinating due to an enlarged prostate glandAsk doctor before use if you are presently taking a prescription for high blood pressure or depression
When using this product Do 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

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)Do not use if tube seal is broken or missingThis product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

Inactive Ingredients

Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Distributed By

Trifecta Pharmaceuticals USA™101 NE Third Avenue, Suite 1500Ft. Lauderdale, FL. 33301, USA1-888-296-9067Product of PRCwww.trifecta-pharma.com

* Please review the disclaimer below.

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