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| Product NDC Code | 80335-105 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Planeaire hands hand sanitizer |
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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(s) 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 Dosage and Administration 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 inner leaf, green tea extract, glycerin, Carbomer, lavender oil, lemon oil, oregano oil, peppermint oil, rosemary oil, thyme oil, 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.Use Hand Sanitizer to help 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, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.PlaneAire Hands hand sanitizer Ethyl Alcohol ALCOHOL ALCOHOL ALOE VERA LEAF POLYSACCHARIDES GLYCERIN LEMON OIL THYME OIL ROSEMARY OIL GREEN TEA LEAF LAVENDER OIL OREGANO LEAF OIL CARBOMER 980 WATER PEPPERMINT 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 - Principal Display Panel 60 mL NDC: 80335-105-02 80335-105-02
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 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
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.The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol. Sodium hydroxide Water. other Inactive ingredients
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 skin 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 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.Stop use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.
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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 15-30C (59-86F) do not store above 105F 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 or flame
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