Abejas Y Viboras Brand Roll-on
FDA Label NDC 53145-703

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Abejas Y Viboras Brand Roll-on (NDC 53145-703). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Menthol 5%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses

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

Warnings

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

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

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

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

Package Label.Principal Display Panel

Abjeasbox (Abejasbox1)

Abjeasbox (Abejasbox1)

Abejasbox2 (Abejasbox2a)

Abejasbox2 (Abejasbox2a)

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