Asperflex Original Maximum Strength also known as Menthol is a human otc drug labeled by 'Akron Pharma Inc.'. National Drug Code (NDC) number for Asperflex Original Maximum Strength is 71399-4461. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Asperflex Original Maximum Strength drug includes Menthol - 210 mg/1 . The currest status of Asperflex Original Maximum Strength drug is Active.
Drug Information:
Drug NDC:
71399-4461
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:
Asperflex Original Maximum Strength
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:
Akron Pharma Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:
Patch
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 - 210 mg/1
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:
04 Nov, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:
14 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, 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:
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
UNII:
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
71399-4461-5
5 PATCH in 1 CARTON (71399-4461-5) / 1 PATCH in 1 PATCH
04 Nov, 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.
Asperflex original maximum strength menthol menthol menthol dihydroxyaluminum aminoacetate anhydrous propylene glycol sodium acrylate tartaric acid hydantoin edetate disodium anhydrous water glycerin
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with: â arthritis â simple backache â strains â sprains â bruises
Warnings:
Warnings for external use only do not use â on wounds, damaged, broken or irritated skin â with a heating pad or apply local heat to the area of use when using this product use only as directed. read and follow all directions and warnings on this carton. do not allow contact with the eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use do not use at the same time as other topical analgesics a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds Read more...
elop â you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away (1-800-222-1222).
Do Not Use:
Warnings for external use only do not use â on wounds, damaged, broken or irritated skin â with a heating pad or apply local heat to the area of use when using this product use only as directed. read and follow all directions and warnings on this carton. do not allow contact with the eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use do not use at the same time as other topical analgesics a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds
When Using:
When using this product use only as directed. read and follow all directions and warnings on this carton. do not allow contact with the eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use do not use at the same time as other topical analgesics a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds
Dosage and Administration:
Directions adults and children 12 years of age and older: â gently fold the patch in half to remove center section of film backing. apply the exposed adhesive portion to the site of pain. â remove remaining film backing from both sides and finish applying to skin â apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if â condition worsens or symptoms persist for more than 7 days â symptoms clear up and occur again within a few days â severe burning sensation, redness or irritation develop â you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Package Label Principal Display Panel:
Carton
Further Questions:
Questions or comments? call toll-free 1-877-255-6999.
Comments/ Reviews:
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.