Alevex
Camphor And Menthol
Bayer Healthcare Llc
Human Otc Drug
NDC 0280-0049Alevex also known as Camphor And Menthol is a human otc drug labeled by 'Bayer Healthcare Llc'. National Drug Code (NDC) number for Alevex is 0280-0049. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Alevex drug includes Camphor (synthetic) - 5.5 mg/g Menthol - 16 mg/g . The currest status of Alevex drug is Active.
Drug Information:
| Drug NDC: | 0280-0049 |
| 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: | Alevex |
| 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: | Camphor And Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bayer Healthcare Llc |
| 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: | CAMPHOR (SYNTHETIC) - 5.5 mg/g
MENTHOL - 16 mg/g
|
| 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 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | Bayer HealthCare 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: | 0025866591561
|
| UPC stands for Universal Product Code. |
| UNII: | 5TJD82A1ET
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 |
|---|
| 0280-0049-01 | 91 g in 1 CAN (0280-0049-01) | 01 Apr, 2021 | 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 pain relieving spray
Product Elements:
Alevex camphor and menthol carbomer interpolymer type a (allyl sucrose crosslinked) isobutane peppermint oil camphor (synthetic) camphor (synthetic) alcohol propanediol rosemary oil propane menthol menthol frankincense oil dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer linseed oil tocopherol 3-((l-menthyl)oxy)propane-1,2-diol isopentane vanillyl butyl ether n-vinylcaprolactam thymus mastichina flowering top oil isopulegol n-vinylpyrrolidinone clove oil dimethyl isosorbide eucalyptus oil
Indications and Usage:
For the temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains sprains bruises provides penetrating pain relief
Warnings:
Warnings for external use only flammable : do not use near heat, flame, or while smoking. do not use if you have ever had an allergic reaction to this product or any of its ingredients when using this product avoid contact with the eyes and mucous membranes use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal contents under pressure. do not puncture or incinerate. do not store at temperature above 120ºf do not bandage tightly do not use with a heating pad, medicated patch or other types of local heat do not apply to wounds or damaged, broken or irritated skin stop use and ask a doctor if condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days if pregnant or breast-feeding, ask a health professional before use. if swallowed, g
Read more...et medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only flammable : do not use near heat, flame, or while smoking. do not use if you have ever had an allergic reaction to this product or any of its ingredients when using this product avoid contact with the eyes and mucous membranes use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal contents under pressure. do not puncture or incinerate. do not store at temperature above 120ºf do not bandage tightly do not use with a heating pad, medicated patch or other types of local heat do not apply to wounds or damaged, broken or irritated skin stop use and ask a doctor if condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days if pregnant or breast-feeding, ask a health professional before use. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with the eyes and mucous membranes use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal contents under pressure. do not puncture or incinerate. do not store at temperature above 120ºf do not bandage tightly do not use with a heating pad, medicated patch or other types of local heat do not apply to wounds or damaged, broken or irritated skin
Dosage and Administration:
Directions adults and children 12 years of age and older shake well before use apply to affected area not more than 3 to 4 times daily do not apply to face use in a well-ventilated area and avoid inhalation wash hands with soap and water after use if product comes in contact with hands children under 12 years of age ask a doctor
Stop Use:
Stop use and ask a doctor if condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Package label display alevex⢠pain relieving spray max strength menthol cools in seconds for external use only net wt 3.2 oz (91 g) alevex dry spray label
Further Questions:
Questions 1-800-395-0689