Hemorroidal Cooling Gel

Phenylephrine, Witch Hazel

Trifecta Pharmaceuticals Usa Llc
Human Otc Drug
NDC 69396-032

Hemorroidal Cooling Gel also known as Phenylephrine, Witch Hazel is a human otc drug labeled by 'Trifecta Pharmaceuticals Usa Llc'. National Drug Code (NDC) number for Hemorroidal Cooling Gel is 69396-032. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hemorroidal Cooling Gel drug includes Phenylephrine Hydrochloride - .25 g/100g Witch Hazel - .5 g/100g . The currest status of Hemorroidal Cooling Gel drug is Active.

Drug Information:

Drug NDC:	69396-032
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Hemorroidal Cooling Gel
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Phenylephrine, Witch Hazel
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Trifecta Pharmaceuticals Usa Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	PHENYLEPHRINE HYDROCHLORIDE - .25 g/100g WITCH HAZEL - .5 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	13 Feb, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part346
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.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Trifecta Pharmaceuticals Usa Llc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0040232622717
UPC stands for Universal Product Code.
UNII:	04JA59TNSJ 101I4J0U34
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Adrenergic alpha1-Agonists [MoA] alpha-1 Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
69396-032-18	1 TUBE in 1 BOX (69396-032-18) / 56 g in 1 TUBE	13 Feb, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Hemorroidal Cooling Gel

Phenylephrine, Witch Hazel

Gel
Trifecta Pharmaceuticals Usa Llc
NDC: 69396-032

Purpose:

Purpose vasoconstrictor

Purpose astringent

Product Elements:

Hemorroidal cooling gel phenylephrine, witch hazel witch hazel witch hazel polysorbate 80 methylparaben sulisobenzone edetate disodium edetic acid phenylephrine hydrochloride phenylephrine aloe vera leaf water sodium citrate propylene glycol .alpha.-tocopherol acetate, d- propylparaben hydroxyethyl cellulose (2000 cps at 1%)

Indications and Usage:

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas

Warnings:

Warnings for external use only ask doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty urinating due to an enlarged prostate gland ask doctor before use if you are presently taking a prescription drug for high blood pressure or depression. when using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator

Dosage and Administration:

Directions children under 12 years of age; ask a doctor before use adults: when practical, clean 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 applying when first opening tube, remove foil seal apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Stop Use:

Stop use and ask a doctor bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain

Package Label Principal Display Panel:

Packaging globe_cooling_gel

Further Questions:

Questions or comments call toll free 1-888-296-9067

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.