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| Product NDC Code | 80295-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Cannavera pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OIL | ||||
| Application Number | part348 | ||||
| Labeler Name | Leading Edge Pharms, 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.Active Ingredients Capsaicin, 0.10% Purpose External Analgesic
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 18 years of age or older • Apply a thin film of oil to affected area and gently rub in until fully absorbed • Wash hands with soap and water after use • Apply to affected area not more than 3 to 4 times daily. Children under 18 years ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Capric Triglycerides, Grape Seed Oil, Rosehip Oil, Passion Fruit Seed Oil, Eucalyptus Leaf Oil, Propanediol, Ethanol SDA 3A, Hemp (Cannabis sativa L.) Leaf Extract, hosphatidylcholine, Aloe Barbadensis Leaf Powder, Sage Leaf Extract, Arnica Leaf Extract, Rosemary Leaf Extract, Bergamot Fruit Oil, Sweet Almond Oil, Tocopherol Acetate, C12-15 Alkyl Benzoate, Lavender Oil, Chamomile Flower Extract, Capryl Glycol, Hexylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate, Ascorbic Acid Tocopherol Acetate, Citric Acid.
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 For temporary relief of minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • bruises • sprains
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.CANNAVERA PAIN RELIEF CAPSAICIN TRICAPRIN GRAPE SEED OIL EUCALYPTUS OIL PROPANEDIOL CANNABIS SATIVA WHOLE ALOE VERA LEAF SAGE ROSEMARY ALMOND OIL .ALPHA.-TOCOPHEROL ACETATE ALKYL (C12-15) BENZOATE LAVENDER OIL CAPRYLYL GLYCOL HEXYLENE GLYCOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE ASCORBIC ACID CITRIC ACID MONOHYDRATE CAPSAICIN CAPSAICIN
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: Label
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
Other information • Store at 15° - 30°C (59° - 86°F)
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. • If you are allergic to any ingredients of this product
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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-536-2872
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 or does not improve after regular use. • Severe burning persists or blistering occurs.
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 • You may experience a burning sensation that generally disappears after several days of regular use. The intensity of this reaction varies among individuals and may be severe. • Avoid contact with the eyes or mucous membranes. • Do not bandage tightly or use with a heating pad.
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR BREASTFEEDING • Ask a health professional before use. • CA AB-45: the FDA strongly advises against the use of cannabis, including CBD, in any form, during pregnancy or while breastfeeding.
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. Read all warnings and directions before use. Test first on small area of skin. IF PREGNANT OR BREASTFEEDING • Ask a health professional before use. • CA AB-45: the FDA strongly advises against the use of cannabis, including CBD, in any form, during pregnancy or while breastfeeding. Do not use. • If you are allergic to any ingredients of this product When using this product • You may experience a burning sensation that generally disappears after several days of regular use. The intensity of this reaction varies among individuals and may be severe. • Avoid contact with the eyes or mucous membranes. • Do not bandage tightly or use with a heating pad. Stop use and ask a doctor if • Condition worsens or does not improve after regular use. • Severe burning persists or blistering occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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