FDA.reportPublic FDA data

Pinceladas Para Hongos Navarro

Manufacturer
Menper Distributors, Inc.
Effective date
2022-02-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:19

Label at a glance#

ProductPinceladas Para Hongos Navarro
Active ingredientUNDECYLENIC ACID
Label structure12 sections

Indications and uses

For the treatment of most athelete's foot, jock itch and ringworm For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch For the relief of itch, scaly skin between toes Clears up most athelete's foot infection and with daily use helps keep it from comming back

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in use of this product. For athelete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athelete's foot and ringworm, use daily for 4 weeks; for ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 20%.................Antifungal

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most athelete's foot, jock itch and ringworm
  • For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch
  • For the relief of itch, scaly skin between toes
  • Clears up most athelete's foot infection and with daily use helps keep it from comming back

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor.
  • for diaper rash

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • For athelete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks.
  • For jock itch, if irritation occurs or if there is no improvement within 2 weeks.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in use of this product. For athelete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athelete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Other information

OTHER SAFETY INFORMATION

  • Protect from freezing. If freezing occurs, warm to room temperature 70°-80° F.
  • TAMPER EVIDENT DISCLOSURE: Do not use if seal is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • isopropyl alcohol 99%, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pinceladas para hongo NavarroPinceladas para hongo Navarro

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1437295undecylenic acid 20 % Topical SolutionPSN3
1437295undecylenic acid 200 MG/ML Topical SolutionSCD3
1437295undecylenic acid 20 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-119-012023-07-28C16284748780-19d75b9d0-2b4e-f424-e053-dadaa90a57ce343573e1-6d65-428d-acaa-5485ed4b7add
53145-119-012022-02-18C16284748780-19d75b9d0-2b4e-f424-e053-dadaa90a57ce343573e1-6d65-428d-acaa-5485ed4b7add
53145-119-012022-01-28C16284748780-19d75b9d0-2b4e-f424-e053-dadaa90a57ce343573e1-6d65-428d-acaa-5485ed4b7add
53145-119-012020-02-27C16284748780-19d75b9d0-2b4e-f424-e053-dadaa90a57ce343573e1-6d65-428d-acaa-5485ed4b7add
53145-119-012020-01-31C16284748780-19d75b9d0-2b4e-f424-e053-dadaa90a57ce343573e1-6d65-428d-acaa-5485ed4b7add

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-119-01Pinceladas Para Hongos Navarro1 in 1 CARTONLIQUID13
53145-119-01Pinceladas Para Hongos Navarro30 mL in 1 BOTTLE, WITH APPLICATORLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53145-119PINCELADAS PARA HONGOS NAVARRO (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.]3Legacy NDC, 2 package rows20220219_343573e1-6d65-428d-acaa-5485ed4b7add.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-11953145-119-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 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
64a6b24b-9dc0-4f8b-be6d-e62e548c572d343573e1-6d65-428d-acaa-5485ed4b7add2022-02-18WarningsExact identifier
spl id: 64a6b24b-9dc0-4f8b-be6d-e62e548c572d
spl set id: 343573e1-6d65-428d-acaa-5485ed4b7add

Reported adverse events (FAERS/openFDA)#

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