Ay Bendito - Thermoactive
Camphor, Menthol
Ay Bendito International, Inc
Human Otc Drug
NDC 72524-604Ay Bendito - Thermoactive also known as Camphor, Menthol is a human otc drug labeled by 'Ay Bendito International, Inc'. National Drug Code (NDC) number for Ay Bendito - Thermoactive is 72524-604. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Ay Bendito - Thermoactive drug includes Camphor (natural) - 6 g/100g Menthol, (+)- - 4 g/100g . The currest status of Ay Bendito - Thermoactive drug is Active.
Drug Information:
| Drug NDC: | 72524-604 |
| 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: | Ay Bendito - Thermoactive |
| 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, Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ay Bendito International, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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 (NATURAL) - 6 g/100g
MENTHOL, (+)- - 4 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: | 22 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | AY BENDITO INTERNATIONAL, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2600910
|
| 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. |
| UNII: | N20HL7Q941
C6B1OE8P3W
|
| 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 |
|---|
| 72524-604-04 | 90 g in 1 BOTTLE, PUMP (72524-604-04) | 22 Jan, 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:
Analgesic
Product Elements:
Ay bendito - thermoactive camphor, menthol water glycerin arnica montana flower water glucosamine sulfate menthol, (+)- menthol, (+)- sodium chondroitin sulfate (porcine; 5500 mw) methylchloroisothiazolinone methylisothiazolinone polysorbate 20 methyl salicylate rosmarinus officinalis flowering top fd&c blue no. 1 camphor (natural) camphor (natural) carbomer 940 trolamine alcohol mineral oil
Indications and Usage:
Aid for temporary local relief of minor pain in muscles or joints.
Warnings:
For external use only.
When Using:
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 transient burning sensation or redness may occur upon application but generally disappears in several days if you experience an allergic reaction, discontinue use and consult a physician do not expose the area treated with product to heat or direct sunlight.
Dosage and Administration:
Adults and children over 12 years: apply a small amount on the area to be. massaged in a circular motion, let set for a few seconds. repeat as necessary, but no more than 3 to 4 times daily. store tightly closed in a dry place at controlled room temperature between 59°-86° f (15°-30° c). processed under the highest standards of quality assurance and good manufacturing practices.
Stop Use:
Condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up occur again within a few days you experience signs injury, such as pain, swelling or blistering where the product was applied.
Use in Pregnancy:
If pregnant or breast â feeding: ask a health professional before use.
Package Label Principal Display Panel:
Ay bendito thermoactive gel