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| Product NDC Code | 43749-510 | ||||
|---|---|---|---|---|---|
| Drug Name | Avedana pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1189156 | ||||
| Application Number | M017 | ||||
| Labeler Name | Unipack LLC | ||||
| 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 ingredients Active ingredients Purpose Natural Menthol USP 9%....................................................Topical Analgesic
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 Directions: Spray to completely cover painful area. Get extra relief by using after warm shower or bath. Reapply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Inactive Ingredients: Arnica montana, Boswellia serrata Extract, Camphor USP, Coconut Oil, Eucalyptus globulus Leaf Oil, Ilex paraguariensis Extract, Isopropyl Alcohol USP, Lavender Oil, Methyl salicylate, Peppermint Oil, Propylene Glycol USP, and Purified 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.Directions Directions: Spray to completely cover painful area. Get extra relief by using after warm shower or bath. Reapply as needed.
Purpose
Information about the drug product’s indications for use.Purpose Active ingredients Purpose Natural Menthol USP 9%....................................................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Avedana Pain Relief Menthol FD&C BLUE NO. 1 ISOPROPYL ALCOHOL PEPPERMINT OIL COCONUT OIL METHYL SALICYLATE ARNICA MONTANA PROPYLENE GLYCOL ILEX PARAGUARIENSIS LEAF LAVENDER OIL BOSWELLIA SERRATA RESIN OIL MENTHOL MENTHOL WATER CAMPHOR (SYNTHETIC) EUCALYPTUS OIL Clear
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.Avedana ® Pain Relieving Spray Made with All - Natural Botanical Ingrdeints. 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 using if you Ask a doctor before using if you: have sensitive skin, are pregnant or are breast feeding.
Stop use and ask a doctor if: Stop use and ask a doctor if: condition worsens, symptoms persist more than 7 days, or clear up and reoccur.
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.When using this product: When using this product: -Avoid contact with eyes and mucous membranes. -Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops.
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: If ingested, seek medical help and contact poison control center immediately.
Safe handling warning
Safe Handling WarningFlammable Keep away from excessive heat or open flames.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store in a cool, dry place with spray cap screwed tightly.
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.
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