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| Product NDC Code | 73287-029 | ||||
|---|---|---|---|---|---|
| Drug Name | Hempvana ultra strength pain relief - overnight |
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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 | ||||
| Application Number | M017 | ||||
| Labeler Name | Telebrands Corp | ||||
| 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 Ingredient Lidocaine 4%
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 Use By Adults Only ■ Apply generously to affected area ■ Massage into painful area until thoroughly absorbed into skin. ■ Repeat as necessary, but no more than 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, Propylene Glycol, Ethylhexyl Palmitate, Stearic Acid, Dimethicone, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Hemp (Cannabis Sativa) Seed Oil, Lavender (Lavandula Angustifolia) Oil, Cocoa (Theobroma Cacao) Seed Butter, Lavender (Lavandula Angustifolia) Flower Extract, English/Roman Chamomile (Chamaemelum Nobile) Flower Extract, Melatonin, Kava (Piper Methysticum) Root Extract, Allantoin, Potassium Cetyl Phosphate, Glycerin, Tocopheryl Acetate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isohexadecane, Hexylene Glycol, Ethylhexylglycerin, Polysorbate 80, Disodium EDTA, Sodium Hydroxide, Red 4 (CI 14700), Blue 1 (CI 42090)
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
Purpose
Information about the drug product’s indications for use.Purpose Lidocaine 4%...... Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Hempvana Ultra Strength Pain Relief - Overnight Lidocaine PEG-100 STEARATE GLYCERYL MONOSTEARATE CANNABIS SATIVA SEED OIL SODIUM HYDROXIDE FD&C RED NO. 4 STEARIC ACID LAVANDULA ANGUSTIFOLIA FLOWER ETHYLHEXYL PALMITATE WATER CETOSTEARYL ALCOHOL GLYCERIN ISOHEXADECANE HEXYLENE GLYCOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) PHENOXYETHANOL DIMETHICONE LAVENDER OIL ALLANTOIN PIPER METHYSTICUM ROOT POTASSIUM CETYL PHOSPHATE ALPHA-TOCOPHEROL ACETATE COCOA BUTTER LIDOCAINE LIDOCAINE PROPYLENE GLYCOL CHAMAEMELUM NOBILE FLOWER MELATONIN SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN FD&C BLUE NO. 1 POLYSORBATE 80 EDETATE DISODIUM ANHYDROUS
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.Hempvana Ultra Strength Pain Relief Cream Lidocaine 4% Overnight Lavender Scent Melatonin + Hemp Seed Oil For Moisturization Net Wt. 3oz (85 g) 1
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 and pets. 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 (855) 877-4503 (M-F, 9am-5pm EST)
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 ■ redness is present or irritation develops
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 ■ use only as directed. Read and follow all directions and warnings on this label. ■ do not bandage tightly or apply local heat (such as heating pads) to the area of use. ■ avoid contact with eyes or mucous membranes. ■ do not apply to wounds or damaged, broken or irritated skin. ■ do not use at the same time as other topical analgesics. ■ do not use in large quantities, particularly over raw surfaces or blistered areas.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional 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 Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ do not bandage tightly or apply local heat (such as heating pads) to the area of use. ■ avoid contact with eyes or mucous membranes. ■ do not apply to wounds or damaged, broken or irritated skin. ■ do not use at the same time as other topical analgesics. ■ do not use in large quantities, particularly over raw surfaces or blistered areas. 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 ■ redness is present or irritation develops If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets. 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