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| Product NDC Code | 80770-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 2605800 | ||||
| Application Number | part341 | ||||
| Labeler Name | NATURAL 17 | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol …………………………………………...………………….……... 2%
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.Mist on a handkerchief or pillow, apply directly on chest or back, or spray in the air.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Alcohol Denat., Aqua, Eucalyptus Globulus Leaf Oil, Isopropyl Alcohol, Propylene Glycol, Parfum, Polysorbate 20, Geraniol, Citronellol, Hydroxycitronellal, Linalool, Coumarin.
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.Breathe Easy Spray is enriched with a blend of refreshing essential oils to clear the senses, restore free breathing, and purify the air. The soothing blend of eucalyptus essential oil and menthol helps ease nasal congestion symptoms.
Purpose
Information about the drug product’s indications for use.Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.MENTHOL MENTHOL POLYSORBATE 20 HYDROXYCITRONELLAL MENTHOL MENTHOL WATER ISOPROPYL ALCOHOL GERANIOL LINALOOL, (+)- COUMARIN EUCALYPTUS GLOBULUS LEAF
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.4oz
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 children’s reach.
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. Avoid contact with eyes. Keep away from flame. Flammable.
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