SPORTS FORMULA

Manufacturer
PROTEGE' MEDIA LLC
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:05

Label at a glance#

ProductSPORTS FORMULA
Active ingredientARNICA MONTANA FLOWER, CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP
Label structure8 sections

Dosage and administration

Liberally apply gel to affected area and rub into joints. Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort. Use no more than 4 times per day. Allow several days for product to take maximum effect. Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)

Label contents#

Full prescribing information#

Active Ingredients                                                                                                    Purpose

OTC - ACTIVE INGREDIENT SECTION

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic
Hemp extract (Cannabis sativa) 1X 7% (15.7mg) HPUS                                          Anti-inflammatory

Approximately 56 applications per container

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Indication:

INDICATIONS & USAGE SECTION

Temporarily relieves pain associated with bruises, sore feet, muscle pain and strains

Warnings:

WARNINGS SECTION

• For external use only. Not for use on open wounds.
• If symptoms persist or worsen, discontinue use, seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
• If rash, redness, irritation or itching occurs, discontinue use.
• If pregnant or breastfeeding ask a health professional before use.
• If diagnosed with psychiatric or mood disorder, seek medical advice before use.
• If swallowed, get medical help or contact a Poison Center.
• Keep out of reach of children.

Directions For Use:

DOSAGE & ADMINISTRATION SECTION

  • Liberally apply gel to affected area and rub into joints.
  • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
  • Use no more than 4 times per day.
  • Allow several days for product to take maximum effect.
  • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)

Other Information:

SPL UNCLASSIFIED SECTION

• Consult a medical professional if using other medications for known interactions.
• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Ethylglycerin, C13-14 isoparaffin, laureth-7, phenoxyethanol, polyacrylamide, purified water, tetrasodium EDTA, virgin olive oil, vitamin E

Comments, Questions or Complaints?

OTC - QUESTIONS SECTION

Call 888-735-4009 or info@promedxnow.com

PRODUCT LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76524-301-022021-07-23C16284748780-1c7ccaba7-277e-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76524-301-02SPORTS FORMULA56 mL in 1 BOTTLELOTION561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76524-301SPORTS FORMULA (ARNICA (A. MONTANA) TINC, HEMP EXTRACT (CANNABIS SATIVA) 1X) LOTION [PROTEGE' MEDIA LLC]1Legacy NDC, 1 package rows20210109_69ffcc27-1f87-4889-869b-209d48c3d15c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76524-30176524-301-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
b8689d00-25b8-535d-e053-2a95a90a30ae69ffcc27-1f87-4889-869b-209d48c3d15c2021-01-08WarningsExact identifier
spl id: b8689d00-25b8-535d-e053-2a95a90a30ae
spl set id: 69ffcc27-1f87-4889-869b-209d48c3d15c

Reported adverse events (FAERS/openFDA)#

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