Arniflora

Manufacturer
Schwabe North America, Inc | Schwabe Mexico, S.A. de C.V.
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 02:35:21

Label at a glance#

ProductArniflora
Active ingredientARNICA MONTANA
Label structure12 sections

Dosage and administration

Directions Apply thin layer to affected area. Massage gently or use compress. For best results, use promptly after injury or trauma occurs. Adults and children 6 years of age and older: apply to affected area up to 4 times daily. Patch test recommended on sensitive skin.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Contains 8% Arnica montana 1X 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer

Ethyl Alcohol

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions

Apply thin layer to affected area. Massage gently or use compress.

For best results, use promptly after injury or trauma occurs.

Adults and children 6 years of age and older: apply to affected area up to 4 times daily.

Patch test recommended on sensitive skin.

Indications & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes and broken skin.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if hypersensitive to this or any ingredients in this product.

Breast-feeding women should not apply to breast area.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

These could be signs of a serious condition.

Pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

If swallowed, seek medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LHBN21825097_01_Arniflora_2_75oz_CTN_FNL.jpgLHBN21825097_01_Arniflora_2_75oz_CTN_FNL.jpg

LHT21825097_01_Arniflora_2_75oz_Tube_FNL.jpgLHT21825097_01_Arniflora_2_75oz_Tube_FNL.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130308078250977GTIN-13: 0308078250977
EAN-13: 0308078250977
GTIN-12: 308078250977
UPC-A: 308078250977
GTIN storage (14 digits): 00308078250977
LHBN21825097_01_Arniflora_2_75oz_CTN_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5090-4Arniflora28 g in 1 TUBEGEL2815
53499-5090-4Arniflora1 in 1 CARTONGEL115
53499-5090-8Arniflora78 g in 1 TUBEGEL7815
53499-5090-8Arniflora1 in 1 CARTONGEL115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW4
ARNICA MONTANAACTIVE MOIETYO80TY208ZW4
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I4
WATERINACTIVE INGREDIENT059QF0KO0R4
WITCH HAZELINACTIVE INGREDIENT101I4J0U344

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
53499-509053499-5090-4, 53499-5090-8

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

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
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 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
ArnifloraARNICA MONTANASchwabe North America, Inc935bf19d-a32c-49b8-a5cc-13e7ddfb23fe2025-11-21WarningsExact identifier
ndc (package): 53499-5090-4
ndc (package): 53499-5090-8
ndc (product): 53499-5090
ndc11 (package): 53499509004
ndc11 (package): 53499509008
spl id: 62116d15-5876-4b4e-9d0b-c48b6a28fd71
spl set id: 935bf19d-a32c-49b8-a5cc-13e7ddfb23fe

Reported adverse events (FAERS/openFDA)#

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