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Phoenix kineticream anti-inflammatory and pain relief - Medication Information

Product NDC Code 65121-032
Drug Name

Phoenix kineticream anti-inflammatory and pain relief

Type Brand
Active Ingredients
Menthol 20 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1102253,
1424356
Application Number M017
Labeler Name Pure Source, LLC
Packages
Package NDC Code Description
65121-032-04 118 ml in 1 tube (65121-032-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Menthol 2.00% Purpose Topical Pain Relief

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 areas Apply to dry and cleans areas Repeat as needed, up to 6 times daily.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporary relieves of these symptoms: minor aches pains associated with simple backache arthritis bruises sprains cramps muscle strains.

Purpose

Information about the drug product’s indications for use.
Purpose Topical Pain Relief

Spl product data elements

Usually a list of ingredients in a drug product.
Phoenix KinetiCream Anti-inflammatory and Pain Relief MENTHOL ALOE VERA LEAF WATER ARNICA MONTANA BROMELAINS SHEA BUTTER C13-14 ISOPARAFFIN GREEN TEA LEAF CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE BERGAMOT OIL DIMETHYL SULFONE EMU OIL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL STEARATE SE LAURETH-7 PEPPERMINT OIL PAPAIN PHENOXYETHANOL POLYSORBATE 20 WILLOW BARK SESAME OIL STEARIC ACID COCOA BUTTER .ALPHA.-TOCOPHEROL XANTHAN GUM MENTHOL MENTHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Labeling: Tube

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if: condition worsen pain persist of more than 7 days irritation develops Avoid contact with eyes and open wounds. If swallowed, get medical help or contact your local Poison Control Center or emergency room immediately.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast feeding ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. Use only as directed children under 6 years, ask a doctor. Stop use and ask a doctor if: condition worsen pain persist of more than 7 days irritation develops Avoid 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. Keep out of reach of children.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API