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Product NDC Code | 83670-202 | ||||
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Drug Name | Joint therapy |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SALVE | ||||
RxCUI drug identifier | 1048263 | ||||
Application Number | M017 | ||||
Labeler Name | Everlaan Organics Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Organic Camphor 4.0%
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: gently massage salve into affected area and apply wet heat use no more than three times per day Children under 2 years of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Organic Arnica Oil, Organic Beeswax, Oganic Coconut Oil, Organic Jojoba Oil, Organic Kokum Butter, Organic Olive Oil, Rosemary Oil, Organic Shea Butter, Organic Sunflower Oil, Vitamin E.
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 joint pain.
Purpose
Information about the drug product’s indications for use.Purpose Organic Camphor 4.0%..............Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Joint Therapy Camphor ROSEMARY OIL .ALPHA.-TOCOPHEROL CAMPHOR (NATURAL) CAMPHOR (NATURAL) ARNICA MONTANA JOJOBA OIL GARCINIA INDICA SEED BUTTER YELLOW WAX COCONUT OIL SHEA BUTTER OLIVE OIL SUNFLOWER 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.maple Plant Based Joint Therapy Temporary Pain Relief Balm Camphor 4% Net Wt. 2 oz / 56 g 1 2
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 this out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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 worsens symptoms persist for more than 7 days or 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.When using this product avoid contact with eyes do not apply to wounds or damaged skin
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Tamper-evident. Ensure seal is intact 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 When using this product avoid contact with eyes do not apply to wounds or damaged skin Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use. Keep this out of the 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