NDC 53145-703 Abejas Y Viboras Brand Roll-on


NDC Product Code 53145-703

NDC 53145-703-03

Package Description: 1 BOTTLE in 1 CARTON > 88 mL in 1 BOTTLE

NDC Product Information

Abejas Y Viboras Brand Roll-on with NDC 53145-703 is a a human over the counter drug product labeled by Menper Distributors Inc.. The generic name of Abejas Y Viboras Brand Roll-on is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Menper Distributors Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Abejas Y Viboras Brand Roll-on Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 5 mg/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Menper Distributors Inc.
Labeler Code: 53145
FDA Application Number: part348 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Abejas Y Viboras Brand Roll-on Product Label Images

Abejas Y Viboras Brand Roll-on Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active IngredientMenthol 5%

Otc - Purpose

PurposeTopical Analgesic

Indications & Usage

  • Usesfor the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthristis, strains and sprains.


  • WarningsFor external use onlyDo not useon wounds or damaged skinwith a heating padon a child 12 years of age and underover extensive areas of the bodyon irritated skinwith a bandagewith other ointments, creams, sprays or linimentsAsk a doctor before use if you have redness over the affected area.When using this productwash hands after use with cool wateravoid contact with eyes or mucous membranesdo not bandageStop use and ask a doctor ifcondition worsens or symptoms persists for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health profiessional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsuse only as directedAdults and children over 12 years: rub a thin film over affected areas not more than 4 times daily: message not necessary.Children 12 years or younger: do not use.

Inactive Ingredient

Inactive ingredients Camphor, carbomer 940, D&C yellow #10, FD&C yellow #5, glycerin, isopropyl myristate, methyl salicylate, methylchloroisothiazolinone, methlylisothiazolinone, polysorbate 20, propylene glycol, triethanolamine, water.

Otc - Questions

Questions? Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

* Please review the disclaimer below.