NDC 58611-032 Phoenix Kineticream Anti-inflammatory And Pain Relief

Menthol

NDC Product Code 58611-032

NDC CODE: 58611-032

Proprietary Name: Phoenix Kineticream Anti-inflammatory And Pain Relief 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: 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

  • 58611 - Phoenix Bioperformance Products, Llc
    • 58611-032 - Phoenix Kineticream Anti-inflammatory And Pain Relief

NDC 58611-032-04

Package Description: 118 mL in 1 TUBE

NDC Product Information

Phoenix Kineticream Anti-inflammatory And Pain Relief with NDC 58611-032 is a a human over the counter drug product labeled by Phoenix Bioperformance Products, Llc. The generic name of Phoenix Kineticream Anti-inflammatory And Pain Relief is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Phoenix Bioperformance Products, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Phoenix Kineticream Anti-inflammatory And Pain Relief 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 20 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • BROMELAINS (UNII: U182GP2CF3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • EMU OIL (UNII: 344821WD61)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PAPAIN (UNII: A236A06Y32)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WILLOW BARK (UNII: S883J9JDYX)
  • SESAME OIL (UNII: QX10HYY4QV)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Phoenix Bioperformance Products, Llc
Labeler Code: 58611
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: 05-22-2013 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Phoenix Kineticream Anti-inflammatory And Pain Relief Product Label Images

Phoenix Kineticream Anti-inflammatory And Pain Relief 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

Menthol 2.00%

Purpose

Topical Pain Relief

Uses

  • Temporary relieves of these symptoms: minor achespains associated with simple backachearthritisbruisessprainscrampsmuscle strains.

Warnings

  • For external use only.Use only as directed children under 6 years, ask a doctor.

Stop Use And Ask A Doctor If:

  • Condition worsenpain persist of more than 7 daysirritation developsAvoid contact with eyes and open wounds.If swallowed, get medical help or contact your local Poison Control Center or emergency room immediately.

If Pregnant Or Breast Feeding

Ask a health professional before use.

Directions

  • Adults and children 6 years and over:Before activity, massage onto muscles and joints until absorbed into skin.After activity, apply generously to tired and affected areasApply to dry and cleans areasRepeat as needed, up to 6 times daily.

Inactive Ingredients:

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), arnica montana (arnica) extract, azadirachta indica (neem) oil, bromelain, butyrospermum parkii (shea) butter, C13-14 isoparaffin, camellia sinensis (green tea) leaf extract, cetearyl alcohol, chondroitin sulfate, citric acid, citrus aurantium bergamia (bergamot) fruit oil, dimethyl sulfone (MSM), emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate SE, laureth-7, mentha piperita (peppermint) oil, papain, phenoxyethanol, polyacrylamide, polysorbate-20, salix alba (willow) bark extract, SD-Alcohol 40B, sesamum indicum (sesame) seed oil, stearic acid, theobroma cacao (cocoa butter), tocopheryl acetate (vitamin E), xanthan gum.

* Please review the disclaimer below.