NDC 76168-403 Hemorrhoidal

Glycerin, Lidocaine

NDC Product Code 76168-403

NDC 76168-403-01

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

NDC Product Information

Hemorrhoidal with NDC 76168-403 is a a human over the counter drug product labeled by Velocity Pharma Llc. The generic name of Hemorrhoidal is glycerin, lidocaine. 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.

Hemorrhoidal 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.

  • 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)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • LAURETH-23 (UNII: N72LMW566G)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • .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.

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: 06-04-2019 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: 12-31-2020 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.

Hemorrhoidal Product Label Images

Hemorrhoidal 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 ingredientsPurposesGlycerin 14.4%ProtectantLidocaine 5%Local anesthetic

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 6 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, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propylene glycol, propylparaben, purified water, stearyl alcohol, white soft paraffin, xanthan gum

Otc - Questions

Questions or comments?Call 888-309-9030

* Please review the disclaimer below.