La Flecha Japonesa

Manufacturer
Menper Distributors, Inc. | RNV, LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:11

Label at a glance#

ProductLa Flecha Japonesa
Active ingredientMETHYL SALICYLATE
Label structure15 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthrits strains sprains

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                                                     Purpose         

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

Purpose 

OTC - PURPOSE SECTION

External Analgesic 

Uses 

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthrits
  • strains
  • sprains

WARNINGS SECTION

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

Do not use 

OTC - DO NOT USE SECTION

  • 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 

OTC - ASK DOCTOR SECTION

redness over the affected area

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • 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 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of the reach of children to avoid accidental poisoning.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions 

DOSAGE & ADMINISTRATION SECTION

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 

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2719838methyl salicylate 10.5 % Topical OilPSN5
2719838methyl salicylate 105 MG/ML Topical OilSCD5
2719838methyl salicylate 10.5 % Topical OilSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-047-01La Flecha Japonesa1 in 1 CARTONOIL15
53145-047-01La Flecha Japonesa15 mL in 1 BOTTLE, GLASSOIL155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
CAJUPUT OILINACTIVE INGREDIENTJ3TO6BUQ371
CLOVE OILINACTIVE INGREDIENT578389D6D01
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
JUNIPER BERRY OILINACTIVE INGREDIENTSZH16H44UY1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-04753145-047-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
8 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates

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
La Flecha JaponesaMETHYL SALICYLATEMenper Distributors, Inc.08819ad0-97c2-49bd-b923-535b94a271672025-07-22WarningsExact identifier
ndc (package): 53145-047-01
ndc (product): 53145-047
ndc11 (package): 53145004701
spl id: 3a89cc64-eb78-0ae0-e063-6394a90a706c
spl set id: 08819ad0-97c2-49bd-b923-535b94a27167

Reported adverse events (FAERS/openFDA)#

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