Abejas Y Viboras Roll On
Methyl Salicylate
Menper Distributors Inc.
Human Otc Drug
NDC 53145-705Abejas Y Viboras Roll On also known as Methyl Salicylate is a human otc drug labeled by 'Menper Distributors Inc.'. National Drug Code (NDC) number for Abejas Y Viboras Roll On is 53145-705. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Abejas Y Viboras Roll On drug includes Methyl Salicylate - 10 g/100g . The currest status of Abejas Y Viboras Roll On drug is Active.
Drug Information:
| Drug NDC: | 53145-705 |
| 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: | Abejas Y Viboras Roll On |
| 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: | Methyl Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Menper Distributors 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: | METHYL SALICYLATE - 10 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: | 31 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | Menper Distributors Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2534482
|
| 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: | LAV5U5022Y
|
| 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 |
|---|
| 53145-705-03 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (53145-705-03) / 88 g in 1 BOTTLE, WITH APPLICATOR | 31 Mar, 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:
Active ingredient purpose methyl salicylate 10% .................... topical analgesic
Product Elements:
Abejas y viboras roll on methyl salicylate water polysorbate 20 arnica montana flower methyl salicylate salicylic acid camphor oil propylene glycol polyacrylic acid (250000 mw) dmdm hydantoin eucalyptus oil capsicum trolamine menthol isopropyl alcohol
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains
Warnings:
Warnings for external use only. do not use on wounds or damaged skin with a heating pad on a child 12 years o age and under over estensive areas of the body on irritated skin with a bandage with other ointments, creams, sprays or liniments ask a doctor before use if you have redness over the affected area when using this product wash hands after use with cool water avoid contact with eyes or mucous membranes do not bandage stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and and occur again within a few days excessive skin irritation occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children to avoid accidental poisoning. if swallowed, induce vomiting and call a physicaian or contact a poision control center right away.
Do Not Use:
Warnings for external use only. do not use on wounds or damaged skin with a heating pad on a child 12 years o age and under over estensive areas of the body on irritated skin with a bandage with other ointments, creams, sprays or liniments ask a doctor before use if you have redness over the affected area when using this product wash hands after use with cool water avoid contact with eyes or mucous membranes do not bandage stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and and occur again within a few days excessive skin irritation occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children to avoid accidental poisoning. if swallowed, induce vomiting and call a physicaian or contact a poision control center right away.
When Using:
When using this product wash hands after use with cool water avoid contact with eyes or mucous membranes do not bandage
Dosage and Administration:
Directions use only as directed adults and children over 12 years: rub a thin film over affected areas not more than 4 times daily children 12 years or younger: do not use
Stop Use:
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and and occur again within a few days excessive skin irritation occurs
Package Label Principal Display Panel:
Principal display panel abejas y viboras external analgesic cream methyl salicylate 10% roll-on pain relieving luquid 3 fl oz (88ml) pdp ayv
Further Questions:
Questions? 1-800-560-5223 m-f 9am â 4 pm eastern