NDC 58443-0268 Performance Brands Steel Releaf Pain Relieving Liquid

Lidocaine Hydrochloride, Menthol

NDC Product Code 58443-0268

NDC Code: 58443-0268

Proprietary Name: Performance Brands Steel Releaf Pain Relieving Liquid What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine Hydrochloride, Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58443 - Prime Enterprises, Inc.
    • 58443-0268 - Performance Brands Steel Releaf

NDC 58443-0268-3

Package Description: 89 mL in 1 BOTTLE

NDC Product Information

Performance Brands Steel Releaf Pain Relieving Liquid with NDC 58443-0268 is a a human over the counter drug product labeled by Prime Enterprises, Inc.. The generic name of Performance Brands Steel Releaf Pain Relieving Liquid is lidocaine hydrochloride, menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Prime Enterprises, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Performance Brands Steel Releaf Pain Relieving Liquid Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 9.5 mg/mL
  • LIDOCAINE 38 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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 (UNII: V95R5KMY2B)
  • EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Prime Enterprises, Inc.
Labeler Code: 58443
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-02-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Performance Brands Steel Releaf Pain Relieving Liquid Product Label Images

Performance Brands Steel Releaf Pain Relieving Liquid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Lidocaine Hydrochloride 4%Menthol 1%

Purpose

Topical Analgesic

Uses

For temporary relief of pain

Warnings

For external use only

Otc - Do Not Use

  • Do not useMore than one recommended dose at a timeOn broken or irritated skinIf you are allergic to any ingredients of this productIn large quantities, particularly over raw surfaces or blistered areas

Otc - When Using

  • When using this productUse only as directedAvoid contact with eyesDo not wrap the treated skin with plastic wrap or other dressings or apply heat to the skin

Otc - Ask Doctor

  • Stop use and ask a doctor ifCondition worsens or symptoms persist for more than 7 days or clear up and occurs againSkin reactions occur, such as rash, itching, redness or irritation

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 overClean and dry affected areaApply once, not to exceed 3 to 4 times dailyRoll on affected area of skinChildren under 12 years of age: Consult a doctor

Other Information

  • Store at 20-25°C (68-77°F)Avoid storing product in direct sunlightProtect product from excessive moistreYou 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)

* Please review the disclaimer below.

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