Prax
Pramoxine Hydrochloride
Ferndale Laboratories, Inc.
Human Otc Drug
NDC 0496-0748Prax also known as Pramoxine Hydrochloride is a human otc drug labeled by 'Ferndale Laboratories, Inc.'. National Drug Code (NDC) number for Prax is 0496-0748. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Prax drug includes Pramoxine Hydrochloride - 10 mg/mL . The currest status of Prax drug is Active.
Drug Information:
| Drug NDC: | 0496-0748 |
| 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: | Prax |
| 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: | Pramoxine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ferndale Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | PRAMOXINE HYDROCHLORIDE - 10 mg/mL
|
| 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: | 01 Apr, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 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, 2023 |
| 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: | Ferndale Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1246075
1246076
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0304960748034
|
| UPC stands for Universal Product Code. |
| UNII: | 88AYB867L5
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0496-0748-03 | 237 mL in 1 BOTTLE (0496-0748-03) | 01 Apr, 2012 | N/A | No |
| 0496-0748-04 | 118 mL in 1 BOTTLE (0496-0748-04) | 01 Apr, 2012 | N/A | No |
| 0496-0748-15 | 15 mL in 1 BOTTLE (0496-0748-15) | 01 Apr, 2012 | 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. |
Purpose:
Purpose local anesthetic
Product Elements:
Prax pramoxine hydrochloride cetyl alcohol diisopropyl adipate dimethicone glycerin petrolatum lanolin hydrogenated coconut oil sorbitan sesquioleate stearyl alcohol mineral oil polyoxyl 40 stearate potassium sorbate povidone water sorbic acid stearic acid trolamine pramoxine hydrochloride pramoxine
Indications and Usage:
Use for the temporary relief of discomfort and itch in the perianal area
Warnings:
Warnings for external use only. do not exceed the recommended daily dosage unless directed by a doctor put this product into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens symptoms do not improve within 7 days allergic reactions develop to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase keep out of reach of children. if swallowed, seek medical attention or contact a poison control center right away.
Do Not Use:
Warnings for external use only. do not exceed the recommended daily dosage unless directed by a doctor put this product into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens symptoms do not improve within 7 days allergic reactions develop to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase keep out of reach of children. if swallowed, seek medical attention or contact a poison control center right away.
Dosage and Administration:
Directions shake well before use. when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. adults and children 12 years of age and older: apply to affected area up to 5 times daily. children under 12 years of age: consult a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens symptoms do not improve within 7 days allergic reactions develop to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase
Package Label Principal Display Panel:
Package label manufactured for ferndale healthcare® inc. by ferndale laboratories, inc. ferndale, mi 48220 u.s.a. toll free (888) 548-0900 www.ferndalehealthcare.com 8 fl oz (237 ml) ndc 0496-0748-03 praxlotion8oz