FDA.reportPublic FDA data

Performance Brands Steel Releaf

Manufacturer
Prime Enterprises, Inc.
Effective date
2022-09-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:52:42

Label at a glance#

ProductPerformance Brands Steel Releaf Pain Relieving Liquid
Active ingredientMENTHOL, LIDOCAINE
Label structure8 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children 12 years and over Clean and dry affected area Apply once, not to exceed 3 to 4 times daily Roll on affected area of skin Children under 12 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • More than one recommended dose at a time
  • On broken or irritated skin
  • If you are allergic to any ingredients of this product
  • In large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

When using this product

  • Use only as directed
  • Avoid contact with eyes
  • Do not wrap the treated skin with plastic wrap or other dressings or apply heat to the skin

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days or clear up and occurs again
  • Skin reactions occur, such as rash, itching, redness or irritation

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over

  • Clean and dry affected area
  • Apply once, not to exceed 3 to 4 times daily
  • Roll on affected area of skin
  • Children under 12 years of age: Consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

Store at 20-25°C (68-77°F)

  • Avoid storing product in direct sunlight
  • Protect product from excessive moistre
  • You may report serious side effects to (800) 555-8895

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Hemp Derived Isolate (HDI), Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa (Turmeric) Root Extract, Glycerin, Harpagophytum Procumbens (Devil's Claw) Root Extract, Mentha Piperita (Peppermint) Oil, Mineral Oil, Oenothera Biennis (Evening Primrose) Oil, Polysorbate 20, Propylene Glycol, Ribes Nigrum (Black Currant) Fruit Extract, Salix Alba (White Willow) Bark Extract, SD Alcohol 40-B, Sodium Hydroxide, Trideceth-6, Water (Aqua)

Steel Releaf® Hemp-Derived Muscle and Joint Formula Pain Relieveing Liquid with Lidocaine and Menthol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-026858443-0268-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
CANNABIDIOL19GBJ60SN5IACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BLACK CURRANT9755T40D11IACT
ALCOHOL3K9958V90MIACT
SODIUM HYDROXIDE55X04QC32IIACT
BORAGE SEED OILF8XAG1755SIACT
GLYCERINPDC6A3C0OXIACT
SALIX ALBA BARK205MXS71H7IACT
TURMERIC856YO1Z64FIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CHAMOMILEFGL3685T2XIACT
PEPPERMINT OILAV092KU4JHIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
HORSE CHESTNUT3C18L6RJAZIACT
MINERAL OILT5L8T28FGPIACT
TRIDECETH-63T5PCR2H0CIACT

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
e9b8a309-86f9-852d-e053-2a95a90add1a8cb94f1d-1e2e-531a-e053-2a95a90a1ba02022-09-28WarningsExact identifier
spl id: e9b8a309-86f9-852d-e053-2a95a90add1a
spl set id: 8cb94f1d-1e2e-531a-e053-2a95a90a1ba0

Reported adverse events (FAERS/openFDA)#

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