PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID- lidocaine hydrochloride, menthol liquid 
Prime Enterprises, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Steel Releaf Pain Relieving Liquid

Active Ingredients

Lidocaine Hydrochloride 4%

Menthol 1%

Purpose

Topical Analgesic

Uses

For temporary relief of pain

Warnings

For external use only

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

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

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

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

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

Directions

Adults and children 12 years and over

Other Information

Store at 20-25°C (68-77°F)

Inactive ingredients

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

Principal Display Label

PERFORMANCE BRANDS STEEL RELEAF  PAIN RELIEVING LIQUID
lidocaine hydrochloride, menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.5 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATER (UNII: 059QF0KO0R)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
BLACK CURRANT (UNII: 9755T40D11)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
GLYCERIN (UNII: PDC6A3C0OX)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
TURMERIC (UNII: 856YO1Z64F)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CHAMOMILE (UNII: FGL3685T2X)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
MINERAL OIL (UNII: T5L8T28FGP)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
Product Characteristics
Colorwhite (White to off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0268-389 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/201910/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/02/201910/31/2024
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0268) , pack(58443-0268) , manufacture(58443-0268) , analysis(58443-0268)

Revised: 9/2022
Document Id: e9b8a309-86f9-852d-e053-2a95a90add1a
Set id: 8cb94f1d-1e2e-531a-e053-2a95a90a1ba0
Version: 4
Effective Time: 20220928
 
Prime Enterprises, Inc.