Cooling Itch Relief
Neilmed Pharmaceuticals, Inc
Human Otc Drug
NDC 13709-310Cooling Itch Relief is a human otc drug labeled by 'Neilmed Pharmaceuticals, Inc'. National Drug Code (NDC) number for Cooling Itch Relief is 13709-310. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Cooling Itch Relief drug includes Hydrocortisone - 1 g/100g . The currest status of Cooling Itch Relief drug is Active.
Drug Information:
| Drug NDC: | 13709-310 |
| 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: | Cooling Itch Relief |
| 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: | Cooling Itch Relief |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Neilmed Pharmaceuticals, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | HYDROCORTISONE - 1 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 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: | 08 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | part348 |
| 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: | NeilMed Pharmaceuticals, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 317564
|
| 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: | 0311917206462
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WI4X0X7BPJ
|
| 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. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 13709-310-01 | 85 g in 1 CAN (13709-310-01) | 08 Nov, 2018 | 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:
Uses temporarily relieves itching associated with minorskin irritation and rashes due to:⢠eczema ⢠poison ivy, oak and sumac ⢠cosmetics⢠psoriasis ⢠soaps and detergents ⢠jewelry⢠insect bites ⢠seborrheic dermatitis
Product Elements:
Cooling itch relief cooling itch relief hydrocortisone hydrocortisone glycerin
Indications and Usage:
Indication & usage for the temporary relief of itching associated with minor skin irritation and rashes due to: ⢠eczema ⢠poison ivy, oak and sumac ⢠cosmetics ⢠jewelry ⢠soaps and detergents ⢠insect bites. other uses of this product should be only under the advice and supervision of a doctor. warnings for external use only. flammable: keep away from fire or flame avoid contact with the eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. do not use for the treatment of diaper rash. consult a doctor. do not puncture or incinerate. contents under pressure. do not store at temperatures above 120Ëf
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product ⢠keep out of eyes. rinse with water to remove ⢠use only as directed. ⢠do not puncture or incinerate. contents under pressure⢠do not store at temperature above 120f
Dosage and Administration:
Dosage and administration see attached image file principal display panel anti itch spray
Stop Use:
Stop use and ask a doctor if ⢠condition worsens or does not improve withing 7 days⢠symptomspersist more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Anti-itch spray anti-itch spray