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| Product NDC Code | 72749-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Painfix relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415975 | ||||
| Application Number | M017 | ||||
| Labeler Name | PainFix LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 5%
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 above 12 years: apply gel to affected area(s) and massage gently until thoroughly absorbed into skin repeat up to 3 to 4 times per day, on an as needed basis after applying, wash hands with soap and water Children 12 years and younger, ask a health professional
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bambusa Vulgaris (Mastic) Sap Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Cinnamomum Cassia Oil, Citrus Aurantium Dulcis (Orange) Extract, Commiphora Myrrha (Myrrh) Extract, Curcuma Longa (Turmeric) Extract, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, MethylSulfonylmethane (MSM), Polysorbate-20, Propylene Glycol, Rheum Palmatum (Rhubarb) Extract, Scutellaria Baicalensis (Skullcap) Extract, Sesamum Indicum (Sesame) Oil, Sodium Hydroxide, Sorbic Acid, Xanthan Gum, Zingiber Officinale (Ginger) Extract
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 temporarily relieves aches and pains of joints and muscles associated with • backache • arthritis • cramps • strains • bruises • sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.PainFix Relief MENTHOL MENTHOL, UNSPECIFIED FORM MENTHOL ALOE VERA LEAF WATER ARNICA MONTANA FLOWER BAMBUSA VULGARIS SAP SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL CETYL ALCOHOL CHINESE CINNAMON OIL ORANGE OIL, COLD PRESSED MYRRH TURMERIC GLYCERIN GLYCERYL LAURATE GLYCERYL 1-UNDECYLENATE ILEX PARAGUARIENSIS LEAF MAGNESIUM SULFATE, UNSPECIFIED FORM DIMETHYL SULFONE POLYSORBATE 20 PROPYLENE GLYCOL RHUBARB SCUTELLARIA BAICALENSIS ROOT SESAME OIL SODIUM HYDROXIDE SORBIC ACID XANTHAN GUM GINGER
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.Packaging PainFix-1
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
YOU GOT THIS Plant-Based www.painfixbody.com Made in USA Manufactured for: PainFix LLC Brooklyn, NY 11201
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. If swallowed, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other Information • store in a cool, dry place, away from direct sunlight
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 Avoid direct contact with eyes. For external use only. When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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