RelieveIt Gel

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:32

Label at a glance#

ProductRelieveIt Gel
Active ingredientARNICA MONTANA
Label structure12 sections

Indications and uses

Arthritis • Osteoarthritis • Backaches • Bursitis • Fibromyalgia • Tendonitis • Joint pain/discomfort • Sciatica • Swelling

Dosage and administration

Adults and children 2 years and over: •Shake well before using •Apply a sufficient amount of RelieveIt® Gel to cover the affected area • Repeat as needed • After applying, wash hands with soap and water Children under 2: consult a doctor

Storage and handling

Do not use if glued carton end flaps are open or if tube seal is broken. Store at 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 1X HPUS: 7%

Purpose

OTC - PURPOSE SECTION

Arthritis • bursitis • Fibromyalgia • Tendonitis • Joint pain/discomfort

  • Sciatica • Swelling • Muscle pulls/aches/soreness

Uses:

INDICATIONS & USAGE SECTION

Arthritis • Osteoarthritis • Backaches • Bursitis •

Fibromyalgia • Tendonitis • Joint pain/discomfort

• Sciatica • Swelling

Warnings:

WARNINGS SECTION

for external use only

When using this product:

OTC - WHEN USING SECTION

use only as directed • avoid contact with eyes

or mucous membranes • do not apply to open

wounds, damaged, or very sensitive skin • do

not use if you are allergic to Arnica montana or to any of this product’s

inactive ingredients • do not apply bandage tightly or use heating pad

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact the

Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over:

•Shake well before using •Apply a sufficient

amount of RelieveIt® Gel to cover the

affected area • Repeat as needed • After

applying, wash hands with soap and water

Children under 2: consult a doctor

Other ingredients:

INACTIVE INGREDIENT SECTION

Calendula officinalis, Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
Eucalyptus, Glycerin, Hydroxypropyl Cellulose,
Isopropyl Myristate, Juniper Oil, Laureth-7, Polyacrylamide, Polyethylene
Glycol 3350, Polysorbate 80, Propyl Gallate,
Propylene Glycol, Purified Water, Resin, Sodium
Hydroxide, Sorbic Acid, Wintergreen, and Xanthan Gum.

*These “Uses” have not been evaluated by the
Food & Drug Administration.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

excessive redness or irritation is present •

condition worsens • pain persists for more than

3 days

If pregnant or breast feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Other Information

STORAGE AND HANDLING SECTION

Do not use if glued carton end flaps are open or if tube seal is broken.

Store at 68-77°F (20-25°C)

Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelingcarton labeling

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-951-022024-01-30C16284748780-11030e365-1e7c-111a-e063-dadaa90a10e2RelieveIt Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-951-02RelieveIt Gel70 g in 1 TUBEGEL702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-951RELIEVEIT GEL (ARNICA MONTANA) GEL [COSMETIC SPECIALTY LABS, INC.]2Legacy NDC, 1 package rows20181115_78d1d0bf-5b4b-947d-e053-2a91aa0ae3f0.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-95158133-951-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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
7a8f771e-e48e-0aa9-e053-2991aa0a161178d1d0bf-5b4b-947d-e053-2a91aa0ae3f02018-11-13WarningsExact identifier
spl id: 7a8f771e-e48e-0aa9-e053-2991aa0a1611
spl set id: 78d1d0bf-5b4b-947d-e053-2a91aa0ae3f0

Reported adverse events (FAERS/openFDA)#

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