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| Product NDC Code | 80335-117 | ||||
|---|---|---|---|---|---|
| Drug Name | Planeaire hands |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1041849 | ||||
| Application Number | M003 | ||||
| Labeler Name | EverywhereAire LLc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl alcohol 70% V/V
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 Wet hands thoroughly with product, rub hands, and allow to dry without wiping For children under 6 years of age, use only under adult supervision to avoid swallowing not recommended for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Vera (Inner Leaf), Bergamot ( Citrus Aurantium Bergamia) Fruit Oil, Coriander (Coriander Sativum) Fruit OIl, Glycerin, Green Tea Extract (Camellia Sinensis Leaf), Lemon Peel ( Citrus Limon) Oil, Orange Peel ( Citrus Aurantium Dulcis) Oil, Pepper (Piper Nigrum) Seed Oil, Tangerine (Citrus reticulata) Fruit Extract, Water ( Aqua)
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 helps reduce bacteria that potentially can cause disease for use when soap and water are not available
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.PlaneAire Hands Hand sanitizer ethanol based LIME OIL CORIANDER OIL ALOE VERA LEAF POLYSACCHARIDES TANGERINE LEMON OIL ALCOHOL ALCOHOL BERGAMOT OIL GREEN TEA LEAF WATER BLACK PEPPER OIL GLYCERIN ORANGE OIL
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.Package Label PlaneAire Hands Lemongrass Rosemary 80335-116
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration Indications and Usage- Uses: Section title changed Section text reformatted to single line reassigned section heading and number, bullets remioved
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 on open wounds or near eyes. In case of contact with eyes, rinse thoroughly with water
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 swallowed, get medical help or contact a local Poison Control Center right away
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.Discontinue use if irritation or redness develops If condtion persists for more than 72 hiurs, consult a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other Information store between 15-30 C ( 59-86 F) do not store above 105 F avoid freezing may discolor some fabrics may be harmful to some wood finishes and plastics
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- on hands Flammable. Keep away from heat and flame Do not use on open wounds or near eyes. In case of contact with eyes, rinse thoroughly with water Discontinue use if irritation or redness develops If condtion persists for more than 72 hiurs, consult a doctor Keep out of reach of children If swallowed, get medical help or contact a local 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