Cool And Heat Pain Relieving Liquid
Menthol
Bionpharma Inc.
Human Otc Drug
NDC 69452-375Cool And Heat Pain Relieving Liquid also known as Menthol is a human otc drug labeled by 'Bionpharma Inc.'. National Drug Code (NDC) number for Cool And Heat Pain Relieving Liquid is 69452-375. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cool And Heat Pain Relieving Liquid drug includes Menthol - 16 mg/100mL . The currest status of Cool And Heat Pain Relieving Liquid drug is Active.
Drug Information:
| Drug NDC: | 69452-375 |
| 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: | Cool And Heat Pain Relieving Liquid |
| 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: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bionpharma Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | MENTHOL - 16 mg/100mL
|
| 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: | 01 Nov, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| 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: | Bionpharma Inc.
|
| 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. |
| UNII: | L7T10EIP3A
|
| 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 |
|---|
| 69452-375-96 | 1 CONTAINER in 1 CARTON (69452-375-96) / 74 mL in 1 CONTAINER | 01 Nov, 2022 | 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 topical analgesic
Product Elements:
Cool and heat pain relieving liquid menthol carbomer interpolymer type b (allyl pentaerythritol crosslinked) propylene glycol trolamine alcohol capsaicin isopropyl myristate glycerin water menthol menthol
Indications and Usage:
Uses temporarily relieves minor muscle and joint pain associated with arthritis simple backache muscle strains sprains bruises.
Warnings:
Warnings for external use only. when using this product: use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a temporary burning sensation may occur after use but normally disappears in several days. if severe burning sensation occurs, discontinue use immediately if swelling or blistering of the skin occurs, stop use and seek medical attention do not expose treated area to heat or direct sunlight. stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days flammable keep away from fire or flame keep out of reach of children . if swallowed, get medical help or contact a poison control center right away. if pregnant or breast-feeding , ask a health professional before use.
When Using:
For external use only. when using this product: use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a temporary burning sensation may occur after use but normally disappears in several days. if severe burning sensation occurs, discontinue use immediately if swelling or blistering of the skin occurs, stop use and seek medical attention do not expose treated area to heat or direct sunlight.
Dosage and Administration:
Directions adults and children over 12 yrs of age : apply to the affected area no more than 3 to 4 times daily if medicine comes in contact with hands, wash with soap and water children 12 years or younger: ask a doctor
Stop Use:
Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Carton *compare to the active ingredient in icy hot® a+health⢠maximum strength cool & heat pain relieving liquid menthol 16% topical analgesic rool-on applicator no mess dries rapidly stain-free 2.5 fl oz (74ml) carton
Further Questions:
Questions & comments? call toll free 1-888-235-2466 (mon - fri 9am - 5pm est)