Ulcerease
Phenol 0.6% Anesthetic Oral Rinse
Crown Laboratories
Human Otc Drug
NDC 0316-0100Ulcerease also known as Phenol 0.6% Anesthetic Oral Rinse is a human otc drug labeled by 'Crown Laboratories'. National Drug Code (NDC) number for Ulcerease is 0316-0100. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Ulcerease drug includes Phenol - 6 mg/mL . The currest status of Ulcerease drug is Active.
Drug Information:
| Drug NDC: | 0316-0100 |
| 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: | Ulcerease |
| 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: | Phenol 0.6% Anesthetic Oral Rinse |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Crown Laboratories |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| 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: | PHENOL - 6 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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 NOT 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: | 28 Mar, 1977 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Jun, 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: | part356 |
| 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: | Crown Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 670451
1598025
|
| 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: | 0303160100062
|
| UPC stands for Universal Product Code. |
| UNII: | 339NCG44TV
|
| 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 |
|---|
| 0316-0100-06 | 178 mL in 1 BOTTLE (0316-0100-06) | 28 Mar, 1977 | 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:
Anesthetic/analgesic
Product Elements:
Ulcerease phenol 0.6% anesthetic oral rinse water phenol phenol sodium borate glycerin sodium bicarbonate
Indications and Usage:
Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.
Warnings:
⢠keep out of reach of children. ⢠not for ingestion. ⢠if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. if sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.
Dosage and Administration:
⢠shake well prior to use. ⢠use full strength as a mouth rinse, rinsing affected area for 15 seconds and spitting out the remainder of the product. ⢠for upper throat, gargle for 15 seconds and spit out. ⢠for adults and children over 12 years of age use every 2 hours or as needed; do not use more than 12 times per day. ⢠children ages 4 months to under 12 years of age, apply to affected area with clean swab. use up to 6 times daily or as directed by physician or dentist. ⢠for teething and hard to reach areas, apply directly to area with tip of clean swab, repeat up to 6 times daily.
Package Label Principal Display Panel:
Ndc 0316-0100-06 ulcer ease ® anesthetic mouth rinse quick pain relief for mouth and upper throat irritations contains: no sugar, no alcohol, no artificial dyes or colorings. pleasant to use. manufactured and distributed by: crown laboratories inc., johnson city, tn 37604 800.334.4286 www.crownlaboratories.com p6028.03 p602803