FDA.reportPublic FDA data

Tintura de Arnica

Manufacturer
Dannso Corp./d.b.a. Essential Products | World Perfume, Inc
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:13

Label at a glance#

ProductTintura de Arnica
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                   Purpose

Isopropyl Alcohol 63-69% by Volume................... Antiseptic

OTC - PURPOSE SECTION

Use

May help prevent skin infection in

  • minor cuts
  • scrapes 
  • burns
  • bruises

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Antiseptic

For External Use Only

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area
  • and dry thoroughly. Apply a thin layer 1 to 3 times daily.
  • May be covered with a sterile bandage, let dry first.

WARNINGS SECTION

Warnings For external use only

Avoid Contact with eyes.

When using this product

  • do not use on irritated skin, in or near eyes or mocous membranes, on wounds or damaged skin, if prone to allergic reaction
  • Fatal if swallowed.

Stop use and ask a doctor if condition persists or gets worse

INACTIVE INGREDIENT SECTION

Inactive Ingredients Arnica Extract, Isopropyl Alcohol, Deionized Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

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
70242-129-012025-01-30C16284748780-19d75b9d0-c51a-f424-e053-dadaa90a57ceArnica Tincture
70242-129-012023-11-15C16284748780-19d75b9d0-c51a-f424-e053-dadaa90a57ceArnica Tincture
70242-129-012020-01-31C16284748780-19d75b9d0-c51a-f424-e053-dadaa90a57ceArnica Tincture

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-129-01Tintura de Arnica30 mL in 1 BOTTLE, PLASTICSOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-129TINTURA DE ARNICA (ISOPROPYL ALCOHOL AND ARNICA EXTRACT) SOLUTION [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]2Legacy NDC, 1 package rows20231116_148dbfdf-13c6-49ef-9c52-220bb1466ed7.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-12970242-129-01

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
ISOPROPYL ALCOHOLND2M416302ACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
eff1a220-7f80-4490-b718-2e654cfb3057148dbfdf-13c6-49ef-9c52-220bb1466ed72023-01-01WarningsExact identifier
spl id: eff1a220-7f80-4490-b718-2e654cfb3057
spl set id: 148dbfdf-13c6-49ef-9c52-220bb1466ed7

Reported adverse events (FAERS/openFDA)#

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