PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID- lidocaine hydrochloride, menthol liquid

Performance Brands Steel Releaf by

Drug Labeling and Warnings

Performance Brands Steel Releaf by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)
TURMERIC (UNII: 856YO1Z64F)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CHAMOMILE (UNII: FGL3685T2X)
SALIX ALBA BARK (UNII: 205MXS71H7)
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

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

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

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0268) , pack(58443-0268) , manufacture(58443-0268) , analysis(58443-0268)