Arnica Gel

Manufacturer
Sled Distribution, LLC
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:41

Label at a glance#

ProductArnica Gel
Active ingredientARNICA MONTANA
Label structure12 sections

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 7%

Purpose

OTC - PURPOSE SECTION

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

INDICATIONS & USAGE SECTION

Uses Temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls 
  • reduces symptoms of bruising such as : discoloration, pain, swelling.

WARNINGS SECTION

WarningsFor external use only.

OTC - DO NOT USE SECTION

Do not use if you are allergic to Arnica montana or any of this product's inactive ingredients.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • dryness or irritation may occur
  • use only as directed
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Conditions persist for more than 3 days or worsens
  • Symptoms clear up and occur again within a few days.

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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.

OTHER SAFETY INFORMATION

Other information do not use if the sachet seal is broken.

INACTIVE INGREDIENT SECTION

Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-005-01Arnica Gel3.5 g in 1 POUCHGEL3.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-005ARNICA GEL (ARNICA MONTANA) GEL [SLED DISTRIBUTION, LLC]2Current NDC, Legacy NDC, 1 package rows20240116_e73c1186-091a-2c57-e053-2995a90a4b02.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-00581417-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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
Arnica GelARNICA MONTANASled Distribution, LLCe73c1186-091a-2c57-e053-2995a90a4b022024-01-15WarningsExact identifier
ndc (package): 81417-005-01
ndc (product): 81417-005
ndc11 (package): 81417000501
spl id: 0f002d6b-b6d7-be6a-e063-6394a90a1e04
spl set id: e73c1186-091a-2c57-e053-2995a90a4b02

Reported adverse events (FAERS/openFDA)#

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