Label: PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID- lidocaine hydrochloride, menthol liquid
- NDC Code(s): 58443-0268-3
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 28, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
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
- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID
lidocaine hydrochloride, menthol liquidProduct 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) 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 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 10/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/02/2019 10/31/2024 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)