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| Product NDC Code | 70983-028 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain release joint and arthritis cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2684923 | ||||
| Application Number | M017 | ||||
| Labeler Name | Saje Natural Business Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 2.667%
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 For people aged 13 and above: Apply to affected area not more than 3-4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Butyrospermum parkii (shea) butter, cetearyl alcohol, cetearyl olivate, copaifera officinalis (balsam copaiba) resin oil, glycerin, glyceryl caprylate, glyceryl undecylenate, origanum majorana (marjoram) leaf oil, pentylene glycol, phenethyl alcohol, propanediol, simmondsia chinensis (jojoba) seed oil, sorbitan olivate, stearic acid, theobroma cacao (cocoa) seed butter, water.
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.For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains
Purpose
Information about the drug product’s indications for use.topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Release Joint and Arthritis Cream Menthol UNDECYLENIC ACID ORIGANUM MAJORANA PROPANEDIOL SORBITAN OLIVATE MENTHOL MENTHOL PHENYLETHYL ALCOHOL GLYCERYL MONOCAPRYLATE SHEA BUTTER COCOA BUTTER SIMMONDSIA CHINENSIS SEED PENTYLENE GLYCOL CETOSTEARYL ALCOHOL CETEARYL OLIVATE WATER GLYCERIN STEARIC ACID COPAIFERA OFFICINALIS RESIN OIL
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.Pain Release Joint Cream outer box label
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 apply • to wounds • on damaged skin • and bandage tightly.
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.Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.For external use only. Avoid contact with the eyes.
Storage and handling
Information about safe storage and handling of the drug product.Store at room temperature and protect from light.
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. Avoid contact with the eyes. Do not apply • to wounds • on damaged skin • and bandage tightly. Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days. Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days. Do not apply • to wounds • on damaged skin • and bandage tightly. For external use only. Avoid contact with the eyes.
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