La Flecha Japonesa Oil
FDA Label NDC 53145-047

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 La Flecha Japonesa (NDC 53145-047). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients                                                                                     Purpose         

Methyl Salicate 10.5%..............................................................External Analgesic

Purpose

External Analgesic 

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • sprains

Warnings

For external use only. Do not use otherwise than as directed.

Do Not Use

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

Ask A Doctor Before Use If You Have

redness over the affected area

When Using This Product

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

Stop Use And Ask A Doctor If

  • condition worsen or symptoms persists for more than 7 days 
  • symptoms clear up 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 The Reach Of Children To Avoid Accidental Poisoning.

If swallowed, induce vomiting and call a physician or contact a Poison Control  Center right away.

Directions

use only as directed

  • adults and children 12 years of age and older: apply to affected area no 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 Ingredients

cajeput oil, clove oil, essential oil of peppermint, eucalyptus oil, juniper, menthol, white mineral oil.

Questions?

1-800-560-5223 M-F 9 AM to 4 PM Eastern.

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