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| Product NDC Code | 73287-016 | ||||
|---|---|---|---|---|---|
| Drug Name | Hempvana ultra strength pain relief cream |
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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 | part348 | ||||
| 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 Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician 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, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Blue 1 (CI 42090), Yellow 5 (CI 19140)
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 minor aches and pains.
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 Cream Lidocaine 4% FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GLYCERYL MONOSTEARATE PEG-100 STEARATE ALLANTOIN .ALPHA.-TOCOPHEROL ACETATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) PHENOXYETHANOL ETHYLHEXYLGLYCERIN ISOHEXADECANE POLYSORBATE 80 BUTYLENE GLYCOL LIDOCAINE LIDOCAINE WATER ETHYLHEXYL STEARATE DIMETHICONE STEARIC ACID MEDIUM-CHAIN TRIGLYCERIDES CANNABIS SATIVA SEED OIL CETOSTEARYL ALCOHOL SUNFLOWER OIL TURMERIC GLYCERIN CAPRYLYL GLYCOL HEXYLENE GLYCOL SODIUM HYDROXIDE EDETATE DISODIUM ANHYDROUS SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
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 with 4% Lidocaine + Hemp Seed Oil Odor Free! Net Wt. 4 OZ (119 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 out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 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.
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. 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