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| Product NDC Code | 80335-109 | ||||
|---|---|---|---|---|---|
| Drug Name | Planreaire hands hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M003 | ||||
| Labeler Name | EverywhereAire 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 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 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, glycerin, green tea extract, polyacrylate crosspolymer-6, safflower seed oil, sandalwood fragrance blend, 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
Spl product data elements
Usually a list of ingredients in a drug product.PlanreAire Hands Hand Sanitizer ETHYL ALCOHOL ALOE VERA LEAF POLYSACCHARIDES SAFFLOWER OIL SANDALWOOD OIL GLYCERIN WATER ALCOHOL ALCOHOL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) GREEN TEA 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.Package Label - Principal Display Panel 60 mL NDC: 80335-109-02 PAH Label 80335-109-02
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.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
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 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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. In case of contact with eyes, rinse eyes thoroughly with water. Stop use if irritation or rash occurs. If condtion persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a local 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. 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