Abejas y Viboras Brand Roll-On

Manufacturer
MENPER DISTRIBUTORS INC.
Effective date
2021-03-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:02:10

Label at a glance#

ProductAbejas y Viboras Brand Roll-On
Active ingredientMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 5%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child 12 years of age and under
  • over extensive 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 persists for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Directions

  • use only as directed
  • Adults 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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AbjeasBoxAbjeasBox

abejasbox2abejasbox2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-703-032023-07-28C16284748780-10191ceaa-6351-198a-e063-dbdaa90aec3e17cd35f6-e0d3-4875-9ca6-1d47d352d7d3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-703-03Abejas y Viboras Brand Roll-On88 mL in 1 BOTTLEGEL885
53145-703-03Abejas y Viboras Brand Roll-On1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53145-703ABEJAS Y VIBORAS BRAND ROLL-ON (MENTHOL) GEL [MENPER DISTRIBUTORS INC.]5Legacy NDC, 2 package rows20210304_17cd35f6-e0d3-4875-9ca6-1d47d352d7d3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-70353145-703-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8515d6ec-4cb3-4394-94ae-c27ec6a84c3817cd35f6-e0d3-4875-9ca6-1d47d352d7d32021-03-01WarningsExact identifier
spl id: 8515d6ec-4cb3-4394-94ae-c27ec6a84c38
spl set id: 17cd35f6-e0d3-4875-9ca6-1d47d352d7d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.