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.

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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

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

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0268
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9.5 mg in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	38 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	white (White to off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0268-3	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2019	10/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/02/2019	10/31/2024

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(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.