Periguard
Otc Skin Protectant Drug Products
Dermarite Industries, Llc
Human Otc Drug
NDC 61924-205Periguard also known as Otc Skin Protectant Drug Products is a human otc drug labeled by 'Dermarite Industries, Llc'. National Drug Code (NDC) number for Periguard is 61924-205. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Periguard drug includes Petrolatum - 49.9 g/100g . The currest status of Periguard drug is Active.
Drug Information:
| Drug NDC: | 61924-205 |
| 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: | Periguard |
| 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: | Otc Skin Protectant Drug Products |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dermarite Industries, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | PETROLATUM - 49.9 g/100g
|
| 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: | 18 Apr, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | part347 |
| 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: | DermaRite Industries, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0714196204042
|
| UPC stands for Universal Product Code. |
| UNII: | 4T6H12BN9U
|
| 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 |
|---|
| 61924-205-04 | 100 g in 1 TUBE (61924-205-04) | 18 Apr, 2011 | N/A | No |
| 61924-205-05 | 5 g in 1 PACKET (61924-205-05) | 18 Apr, 2011 | N/A | No |
| 61924-205-07 | 198 g in 1 TUBE (61924-205-07) | 18 Apr, 2011 | N/A | No |
| 61924-205-15 | 15 g in 1 PACKET (61924-205-15) | 18 Apr, 2011 | 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: skin protectant
Product Elements:
Periguard otc skin protectant drug products aloe vera leaf aluminum stearates white wax corn oil cholecalciferol vitamin a palmitate chloroxylenol imidurea methylparaben propylene glycol propylparaben lanolin mineral oil paraffin petrolatum petrolatum phenoxyethanol sorbitan sesquioleate .alpha.-tocopherol acetate water zinc oxide
Indications and Usage:
Uses: a moisture barrier that prevents and helps treat skin irritation from urine, feces, perspiration, conditions associated with diaper rash from incontinence.
Warnings:
Warnings: for external use only. avoid contact with eyes. in case of contact, flush thoroughly with water. stop use and ask doctor if condition worsens or does not improve within 7 days. in case of accidental ingestion contact a physician or poison control center right away.
Dosage and Administration:
Directions: cleanse skin gently with a mild cleanser. pat dry or allow to dry. apply a thin layer of ointment to the affected area as necessary, or after each incontinent episode or diaper change to promote comfort and long lasting protection.
Package Label Principal Display Panel:
Periguard package label principal display panel periguard
Further Questions:
Questions? call 1-800-37-6296