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| Product NDC Code | 71630-098 | ||||
|---|---|---|---|---|---|
| Drug Name | On guard sanitizing gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581662 | ||||
| Application Number | M003 | ||||
| Labeler Name | doTERRA International, 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 Purpose Ethyl Alcohol 70% v/v ......................... Antiseptic
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 • Wet hands thoroughly and allow to dry without wiping. • For children under 5, use adult supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Eucalyptus Oil, Citrus aurantium dulcis (Orange) Peel Oil, Hydroxypropyl Guar, Eugenia caryophyllus (Clove) Bud Oil, Cinnamomum zeylanicum Leaf Oil, Pyrus malus (Apple) Fruit Extract, Glycerin, Cinnamomum zeylanicum Bark Oil, Eucalyptus globulus Leaf Oil, Rosmarinus officinalis (Rosemary) Leaf/Stem Oil, Citric Acid
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 Uses • Reduces bacteria on hands[skin] • Recommended for repeated use
Purpose
Information about the drug product’s indications for use.Antiseptic, Hand Sanitizer Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.On Guard Sanitizing Gel Alcohol WATER EUCALYPTUS OIL ORANGE OIL HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) CLOVE OIL CINNAMON LEAF OIL GLYCERIN CINNAMON BARK OIL HYDRATED SILICA BORON ALCOHOL ALCOHOL EUCALYPTUS GLOBULUS LEAF ROSEMARY 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.Primary Label Primary Label Primary Panel
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 immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Store at a temperature below 38°C (100°F) • Do not use if quality seal is broken
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-411-8151
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 and redness develop.
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 avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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 Warnings Flammable. Keep away from flame, spark, or temperatures above 40°C (104°F) 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