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Product NDC Code | 71282-011 | ||||
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Drug Name | 4jointz |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1045482 | ||||
Application Number | M017 | ||||
Labeler Name | ARP(USA) Pty Ltd | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Menthol 1.5%
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 Use only as directed ■ adults & children 12 years and older: massage gently into affected joints ■ apply three (3) times daily for optimal results
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive ingredients Aloe barbadensis leaf gel, caprylyl glycol, castor oil, cetyl alcohol, deionized water, dimethicone, disiloxane,eucalypyus oil, frankincense oil, glycerin, glyceryl stearate, olive oil, PEG-100 stearate, phenoxyethanol, propylene glycol, SD alcohol, sodium hydroxide, sorbic acid, symphytum officinale (comfrey), tannic acid, urea, 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 Temporarily relieves the aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ 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.4Jointz Menthol MENTHOL MENTHOL ALOE VERA LEAF CAPRYLYL GLYCOL CASTOR OIL CETYL ALCOHOL DIMETHICONE HEXAMETHYLDISILOXANE EUCALYPTUS OIL FRANKINCENSE OIL GLYCERIN GLYCERYL MONOSTEARATE OLIVE OIL PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL ALCOHOL SODIUM HYDROXIDE SORBIC ACID SYMPHYTUM OFFICINALE WHOLE TANNIC ACID UREA WATER XANTHAN GUM
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.4JOINTZ ® Principal Display Panel Live Pain Free 4JOINTZ ® FREEDOM TO MOVE Pain Relief Cream www.4jointz.com 2 X 3.5 oz [100g] tubes – 7 oz [200g] total Clinically Tested Long Lasting Results 4JOINTZ® FREEDOM TO MOVE Uniquely Formulated for Painful, Stiff & Swollen Joints 4JOINTZ ® FREEDOM TO MOVE Nature & Science Combined 4JOINTZ ® FREEDOM TO MOVE Nature & Science Combined 0 80119 61913 3 Manufactured for ARP (USA) Pty Ltd, 2A, Ground Floor, 15 Lake St. Varsity Lakes QLD 4227 Australia. Visit www.4Jointz.com for further details and to see how 4Jointz has helped people just like you. Net wt. 7oz (200g). Patent: www.4jointz.com/patent Made in the USA of US and imported materials ↓Inner Package↓ res 4Jointz Box V5 4Jointz Tube V5
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Discontinue use and consult a doctor if ■ conditions worsen or symptoms persists for more than 7 days or clear up and occur again within a few days ■ redness or irritation develops
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ■ on open wounds or abraded skin or while nursing ■ on a child under 12 years of age with arthritis-like conditions ■ near the eyes or on mucous membranes ■ with a heating pad or bandage tightly over the area
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store below 30°C (86°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-844-4JOINTZ (1-844-456-4689)
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.
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