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| Product NDC Code | 73287-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Hempvana cold as ice gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| 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 Menthol USP 8% w/w
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.Call (855) 877-4503 (M-F, 9am-5pm EST) Does not contain NSAIDS, ibuprofen, Aspirin or Salicylate For more information visit www.hempvana.com 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: Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water. For children under 18 years of age : Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water/aqua/eau, alcohol denat., isopropyl myristate, sodium hydroxide, silica silylate, hemp seed oil, camphor, aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, curcuma longa (turmeric) root extract, ilex paraguariensis leaf extract, melissa officinalis flower/leaf/stem extract, phenoxyethanol, carbomer, ethylhexylglycerin, disodium edta, tocopheryl acetate, Yellow 5 (Cl 19140), Blue 1 (Cl 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 temporarily relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains
Purpose
Information about the drug product’s indications for use.Purpose Menthol USP 8% w/w................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Hempvana Cold as Ice Gel Menthol ISOPROPYL MYRISTATE SODIUM HYDROXIDE MENTHOL MENTHOL WATER CAMPHOR, (-)- TURMERIC CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALPHA-TOCOPHEROL ACETATE GREEN TEA LEAF MELISSA OFFICINALIS FLOWERING TOP EDETATE DISODIUM EDETIC ACID FD&C BLUE NO. 1 ALCOHOL SILICA DIMETHYL SILYLATE ILEX PARAGUARIENSIS LEAF PHENOXYETHANOL ETHYLHEXYLGLYCERIN FD&C YELLOW NO. 5 GLYCERIN CANNABIS SATIVA SEED OIL ALOE VERA LEAF ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER CALENDULA OFFICINALIS FLOWERING TOP
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.Cold Therapy For Pain Hempvana #1 Hemp Brand in America Cold as Ice Pain Relief Gel Enriched with hemp seed oil turmeric and aloe Menthol USP 8% For arthritis, back, shoulder, joint & muscle pain phthalate free - paraben free - vegan - gluten free - cruelty free 4 fl oz (118 mL) As seen on TV PDP
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 . If product is swallowed, get medical help or contact a Poison Control Center right away.
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
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, avoid contact with eyes. Do not apply to wounds or damaged skin Do nut use in large quantities, particularly over raw surfaces or blistered areas. Do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or nursing, ask a healthcare professional before using.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store tightly closed in a cool dry place.
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.For external use only Flammable : Keep away from excessive heat or open flame When using this product, avoid contact with eyes. Do not apply to wounds or damaged skin Do nut use in large quantities, particularly over raw surfaces or blistered areas. Do not bandage tightly 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 Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away. If pregnant or nursing, ask a healthcare professional before using.
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