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Product NDC Code | 73287-001 | ||||||
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Drug Name | Hempvana pain relief |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
Application Number | M017 | ||||||
Labeler Name | Telebrands Corp | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Trolamine Salicylate 10%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Hempvana ® Pain Relief Cream absorbs quickly and goes to work instantly. Its unique formula includes a proven active ingredient plus the moisturizing benefit of cold pressed hemp seed* extract for soothing relief to back, neck, shoulders, feet, wrists, calves and more. Maximum Strength Odor Free Non-Irritating No Burning Non Greasy TAMPER EVIDENT: Do not use if safety seal on cap is broken or missing. For more information, visit www.HempvanaStore.com *Complies with Federal Law. Hemp seed extract in the form of oil made by cold-pressing industrial hemp seeds. cultivar. Dist. by: Telebrands Corp. 79 Two Bridges Road, Fairfield, NJ 07004
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 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, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Hemp Seed Oil (Hemp Seed Oil), Glyceryl Stearate, PEG-100 Stearate, Cetostearyl Alcohol, Sunflower Oil, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Isohexadecane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Hexylene Glycol, Polysorbate 80, Disodium EDTA, D&C Green No. 5 (CI 61570), Sodium Hydroxide, Phenoxyethanol
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 minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises
Purpose
Information about the drug product’s indications for use.Purpose Trolamine Salicylate 10%................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Hempvana Pain Relief Trolamine Salicylate WATER ETHYLHEXYL STEARATE BUTYLENE GLYCOL DIMETHICONE STEARIC ACID MEDIUM-CHAIN TRIGLYCERIDES CANNABIS SATIVA SEED OIL GLYCERYL MONOSTEARATE PEG-100 STEARATE CETOSTEARYL ALCOHOL SUNFLOWER OIL ALLANTOIN .ALPHA.-TOCOPHEROL ACETATE, DL- ETHYLHEXYLGLYCERIN ISOHEXADECANE SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CAPRYLYL GLYCOL HEXYLENE GLYCOL POLYSORBATE 80 EDETATE DISODIUM ANHYDROUS D&C GREEN NO. 5 SODIUM HYDROXIDE PHENOXYETHANOL TROLAMINE SALICYLATE SALICYLIC ACID
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.Packaging Hempvana Maximum Strength Pain Relief Cream Original +Hemp Seed Oil Trolamine Salicylate 10% For Pain Odor Free! Net Wt. 4 OZ (119 g) 1
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
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.
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