FDA.reportPublic FDA data

Muscle Therapy with Arnica Pain Relief Gel

Manufacturer
Hyland’s Inc. | Hyland's Inc
Effective date
2024-09-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:54:11

Label at a glance#

ProductMuscle Therapy with Arnica Pain Relief Gel
Active ingredientARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP, RHODODENDRON TOMENTOSUM LEAFY TWIG
Label structure9 sections

Indications and uses

Temporarily relieves the symptoms of pain, bruising, muscle soreness and swelling due to overexertion or injury.

Dosage and administration

Adults and children 6 years and over: ■ Apply liberally to affected area. ■ Repeat until relieved, up to 4 times per day. ■ Do not use other than directed.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Temporarily relieves symptoms of pain, bruising, muscle soreness and
swelling due to overexertion or injury.

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Arnica Montana 1X HPUSbruising, swelling, stiffness, muscle soreness and pain
Bellis Perennis 2X HPUSsprains, swelling and sore muscles
Hypericum Perforatum 2X HPUSradiating pains
Ledum Palustre 2X HPUSpain
Ruta Graveolens 2X HPUSsprains and twist

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of pain, bruising, muscle soreness and swelling due to overexertion or injury.

Warnings

WARNINGS SECTION

For external use only. Keep away from eyes.

Do not use

OTC - DO NOT USE SECTION

on open wounds.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ pain gets worse or lasts more than 7 days.
■ new symptoms occur. ■ redness or swelling persists or worsens.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and over: ■ Apply liberally to affected area. ■ Repeat until relieved, up to 4 times per day. ■ Do not use other than directed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbopol ® Ultrez 21 Polymer, Ethyl Alcohol, Purified Water, Sodium Hydroxide

Dosage and Administration (Directions)

RECENT MAJOR CHANGES SECTION

Adults and children 6 years and over:  Apply liberally to affected area.
 Repeat until relieved, up to 4 times per day.  Do not use other than directed.

Principal Display Panel - 70.9 Grams Gel Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

MUSCLE

THERAPY

-WITH ARNICA-

PAIN RELIEF GEL*

SORENESS SWELLING

STIFFNESS BRUISING

HOMEOPATHIC

2.5 OZ. (70.9 GRAMS) MGEL Carton ArtMGEL Carton Art

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3203MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL (ARNICA MONTANA,BELLIS PERENNIS,HYPERICUM PERFORATUM,RUTA GRAVEOLENSFLOWERING TOP AND RHODODENDRON TOMENTOSUM LEAFY TWIG) GEL [HYLAND’S INC.]6Legacy NDC20240927_74326a86-ff50-4597-e053-2991aa0ab959.zip

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
54973-320354973-3203-1, 54973-3203-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
ARNICA MONTANAO80TY208ZWACTIB
BELLIS PERENNIS2HU33I03UYACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB

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
4f9bcf03-28d6-5432-e063-6294a90a426774326a86-ff50-4597-e053-2991aa0ab9592026-04-16WarningsExact identifier
spl set id: 74326a86-ff50-4597-e053-2991aa0ab959

Reported adverse events (FAERS/openFDA)#

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