NDC 55629-051 Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride

Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride

NDC Product Code 55629-051

NDC CODE: 55629-051

Proprietary Name: Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride 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, Petrolatum, And Phenylephrine Hydrochloride 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

  • 55629 - One2zee Limited Liability Company
    • 55629-051 - Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride

NDC 55629-051-04

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC Product Information

Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride with NDC 55629-051 is a a human over the counter drug product labeled by One2zee Limited Liability Company. The generic name of Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride is glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: One2zee Limited Liability Company

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.

Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride 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
  • PETROLATUM 150 mg/g
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 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 (UNII: K679OBS311)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • LAURETH-23 (UNII: N72LMW566G)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)

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: One2zee Limited Liability Company
Labeler Code: 55629
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: 02-08-2021 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 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.

Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride Product Label Images

Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride 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:

Glycerin 14.4%Lidocaine 5%Phenylephrine HCl 0.25%White petrolatum 15%

Purpose

  • ProtectantLocal anestheticVasoconstrictorProtectant

Uses:

  • For temporary relief of pain, soreness and burningHelps relieve the local itching and discomfort associated with hemorrhoidsTemporarily shrinks hemorrhoidal tissueTemporarily provides a coating for relief of anorectal discomfortsTemporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful

Warnings:

  • Ask a doctor before use if you haveAsk a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

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 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

Inactive Ingredients:

Aloe vera leaf, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monosterate, methylparaben, mineral oil, laureth-23, steareth-2, steareth-20, propyl gallate, propylene glycol, propylparaben, sodium benzoate, tocopherol, alpha.- tocopherol acetate, xanthan gum, water

Other Information:

Store at 20-25°C (68-77°F) Do not use if tamper evident packaging has been breached or is missing.Distributed by: Wellspring Airmont, NY 10952 U.S.A.

* Please review the disclaimer below.