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| Product NDC Code | 69145-201 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Desert harvest releveum |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 1421893 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Desert Harvest 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: Lidocaine, USP 4% 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: Apply a thin, even later up to 4 times daily or as directed by a qualified healthcare practitioner. Wash hands after use. Adults and children 2 years of age and older: Children under 2 years of age and pregnant/breastfeeding women, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Deionized Water, Certified Organic Aloe Barbadensis Leaf Juice, Glyceryl Stearate (Natural Skin Lubricant), Stearic Acid (Plant-based Fatty Acid), Cartharnus Tinctorius (Safflower) Seed Oil, Rosa Canina (Rosehips) Fruit Oil, Sodium Ascorbyl Phosphate (Vitamin C), Salvia Sin-ensis (Chia) Seed Oil, Vegetable Glycerin, Cetyl Alcohol (from Coconut Oil), Carbomer (Natural Thickener), Calendula Officitialis (Pot Marigold) Flower i Extract, Chamomilla Recutita (Chamomile) Flower Extract, Matrlcarla Cha-mornilla (Roman Chamomile) Flower Extract, Tilia Oficinalis (Linden) Ex-tract, Hypericum Perforatum (St. John's Wort) Extract, Centaurea Cyanus (Cornflower) Extract, Vitis Vinifera (Grape) Seed Extract, Tabebuia Impetiginosa (Pau d'Arco) Extract, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Tocopheryl Acetate (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate (Natural Antimicrobial), Lonicera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Populus Tremuloides (Aspen) Bark Extract, Gluconolactone (Natural Skin Conditioner)
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 the temporary relief of pain associated with minor burns.
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.Desert Harvest RELEVEUM LIDOCAINE WATER ALOE VERA LEAF GLYCERYL MONOSTEARATE STEARIC ACID SAFFLOWER OIL ROSA CANINA FRUIT OIL SODIUM ASCORBYL PHOSPHATE CHIA SEED OIL GLYCERIN CETYL ALCOHOL CALENDULA OFFICINALIS FLOWER CHAMOMILE CHAMAEMELUM NOBILE FLOWER TILIA CORDATA FLOWER ST. JOHN'S WORT CENTAUREA CYANUS FLOWER VITIS VINIFERA SEED TABEBUIA IMPETIGINOSA WHOLE CAMELLIA OLEIFERA LEAF .ALPHA.-TOCOPHEROL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE LONICERA JAPONICA FLOWER LONICERA CAPRIFOLIUM FLOWER POPULUS TREMULOIDES BARK GLUCONOLACTONE LIDOCAINE LIDOCAINE
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.Desert Harvest RELEVEUM Releveum4oz Releveum8oz
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.Desert Harvest RELEVEUM
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.Stop use and ask a doctor if: condition worsens a rash or irritation develops
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. Do not use on open wounds. Avoid contact with eyes. Keep out of reach of children. Stop use and ask a doctor if: condition worsens a rash or irritation develops
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