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| Product NDC Code | 73287-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Hempvana cold as ice pain relief gel-patch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| 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 5%
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 over 12 years of age Clean and dry affected area follow application insructions above to apply patch to skin Apply one patch to affected area no more than 3-4 times daily Remove patch from affected area after maximum of 8 hour application Children uner 12 years of age : consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, 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 pain
Purpose
Information about the drug product’s indications for use.Purpose Menthol 5%................Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Hempvana Cold As Ice Pain Relief Gel-Patch Menthol WATER DIHYDROXYALUMINUM AMINOACETATE GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 POVIDONE PROPYLENE GLYCOL PROPYLPARABEN SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE 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.Hempvana Menthol Patch
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 not use more than one patch at a time on wounds, cuts, damaged, broken and/or irritated skin over raw surfaces or blistered areas at the same time as other topical analgesics if allergic to menthol or any inactive ingredients if package is damaged or opened
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 ingested, 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Avoid storing patches in direct sunlight. Protect patches from excessive moisture
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 Do not use more than one patch at a time on wounds, cuts, damaged, broken and/or irritated skin over raw surfaces or blistered areas at the same time as other topical analgesics if allergic to menthol or any inactive ingredients if package is damaged or opened 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 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 ingested, 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