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| Product NDC Code | 43749-321 | ||||
|---|---|---|---|---|---|
| Drug Name | Avedana cool hot ice |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 311502 | ||||
| Application Number | part348 | ||||
| Labeler Name | Unipack, Inc. | ||||
| 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 Active Ingredients Purpose Menthol 2%..................................................External Pain Reliever
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 -Adult and children 2 years of age and older. Clean skin thoroughly. Apply liberally to affected area no more than 3-4 times daily. No protective cover needed. -May be used with ice packs -May be used with wet or dry bandages, but wrap loosely -Children under 2 years of age, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other ingredients Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide
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 pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises
Purpose
Information about the drug product’s indications for use.Purpose External Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Avedana Cool Hot Ice Menthol MENTHOL MENTHOL CAMPHOR (SYNTHETIC) PROPYLENE GLYCOL ISOPROPYL ALCOHOL SODIUM HYDROXIDE CARBOMER HOMOPOLYMER TYPE C FD&C BLUE NO. 1 WATER
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.Product Label Product Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use Ask doctor before use if you have sensitive skin
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 Do not use - internally - with heating pad or devices - on wounds or damaged skin
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 Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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 When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Other information store between 59 o - 86 o F (15 o - 30 o C) Keep tightly closed Do not use, pour, spill, or store near heat or open flame
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 Warnings For external use only. Avoid contact with eyes
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