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| Product NDC Code | 73287-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Hempvana cold as ice pain relief |
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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
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 produce comes in contact with hands, wash with soap and water. For children under 18 years of age: Consulta a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Arctium Lappa Root Extract, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Cannabis Sativa Seed Oil, Carbomer, FD&C Blue No 1, FD&C Yellow No 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water
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 Pain Relief Menthol WATER ETHYLHEXYL STEARATE ARCTIUM LAPPA ROOT ALOE VERA LEAF ILEX PARAGUARIENSIS LEAF ARNICA MONTANA FLOWER FRANKINCENSE CALENDULA OFFICINALIS WHOLE GREEN TEA LEAF CAMPHOR (NATURAL) CANNABIS SATIVA SEED OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GLYCERIN ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE MELISSA OFFICINALIS SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE TROLAMINE D&C GREEN NO. 5 SODIUM HYDROXIDE PHENOXYETHANOL MENTHOL MENTHOL
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 Roll On
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do nut use in large quantities, particularly over raw surfaces or blistered areas. Do not apply to wounds or damaged skin Do not bandage tightly
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.
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
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.
Storage and handling
Information about safe storage and handling of the drug product.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.Warnings For external use only Flammable : Keep away from excessive heat or open flame When using this product, avoid contact with eyes. Do nut use in large quantities, particularly over raw surfaces or blistered areas. Do not apply to wounds or damaged skin 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.
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