NDC 76168-323 Hemorrhoid Relief

Glycerin, Lidocaine, Phenylephrine Hcl And White Petrolatum

NDC Product Code 76168-323

NDC CODE: 76168-323

Proprietary Name: Hemorrhoid Relief 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: Glycerin, Lidocaine, Phenylephrine Hcl And White Petrolatum 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 product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.
  • This medication is used to relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 76168 - Velocity Pharma Llc

NDC 76168-323-30

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC Product Information

Hemorrhoid Relief with NDC 76168-323 is a a human over the counter drug product labeled by Velocity Pharma Llc. The generic name of Hemorrhoid Relief is glycerin, lidocaine, phenylephrine hcl and white petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Velocity Pharma 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.

Hemorrhoid Relief 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.

  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PETROLATUM 150 mg/g
  • GLYCERIN 144 mg/g
  • LIDOCAINE 50 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.
  • 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: Velocity Pharma Llc
Labeler Code: 76168
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: 10-25-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hemorrhoid Relief Product Label Images

Hemorrhoid Relief 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

Other

Drug Facts

For external use only

Otc - Purpose

Active ingredientsPurposesGlycerinProtectantLidocaineLocal anestheticPhenylephrine HClVasoconstrictorWhite PetrolatumProtectant

Indications & Usage

  • Usesfor temporary relief of pain, soreness and burninghelps relieve the local itching and discomfort associated with hemorrhoidstemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful

Warnings

Warnings

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

Stop Use And Ask A Doctor If

  • Rectal 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsadults: 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 a soft cloth before applying this cream.apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementchildren under 12 years of age: ask a doctor

Storage And Handling

Other informationstore at 20–25°C (68–77°F)

Inactive Ingredient

Inactive ingredientsaloe vera gel, benzyl alcohol, butylated hydroxy toluene, carboxymethylcellulose sodium, cetomacrogol 1000, cetyl alcohol, cetyl alcohol, citric acid, disodium EDTA, glyceryl monostearate, light liquid paraffin, propylene glycol, purified water, stearyl alcohol, Vitamin E, xanthan gum

Otc - Questions

Questions or comments?Call 1-855-314-1850

* Please review the disclaimer below.