Mascura La Vaca Plus
FDA Label NDC 53145-082

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 Mascura La Vaca Plus (NDC 53145-082). 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 - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients   Purpose

Methyl Salicylate 10.5%...............External analgesic

Otc - Purpose

Purpose

External analgesic

Indications & Usage

Uses

  • For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains.

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age
  • over extensive areas of the body
  • on irritated skin
  • with a bandage

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

Otc - When Using

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage

Otc - Stop Use

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 professional 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 Posion Control Center right away.

Dosage & Administration

Directions

  • use only as directed
  • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor.

    • Other information

    • store at 15 to 25 C (59 to 77 F)

Inactive Ingredient

Inactive ingredients

Camphor, D&c red #17, fragrance, menthol, methylparaben, paraffin wax, propylparaben, and white petrolatum.

Otc - Questions

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

Package Label.Principal Display Panel

Vacared (Lavacamascuraplusred)

Vacared (Lavacamascuraplusred)

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