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| Product NDC Code | 71630-383 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | On guard sanitizing wipes |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CLOTH | ||||||
| RxCUI drug identifier | 1489307 | ||||||
| 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(s) Ethyl Alcohol 70% v/v. Purpose: 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 Wet hands thoroughly with wipe and allow to dry without rinsing. Throw away after use. Do not flush.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Glycerin, Citrus aurantium dulcis (Orange) Peel Oil, Eugenia caryophyllus (Clove) Bud Oil, Cinnamomum zeylanicum Leaf Oil, Cinnamomum zeylanicum Bark Oil, t-butyl Alcohol, Eucalyptus globulus Leaf Oil, Rosmarinus officinalis (Rosemary) Leaf/Stem Oil, Camellia sinensis Leaf Extract, Denatonium Benzoate, Aloe barbadensis Leaf Extract, Althaea officinalis Root Extract, Chamomilla recutita (Matricaria) Flower Extract, Cucumis sativus (Cucumber) Fruit Extract, Avena sativa (Oat) Kernel Extract.
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 •Decreases bacteria on hands [skin]. •Recommended for repeated use.
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.On Guard Sanitizing Wipes ALCOHOL AVENA SATIVA WHOLE DENATONIUM BENZOATE MATRICARIA RECUTITA FLOWERING TOP EUCALYPTUS OIL WATER ALCOHOL ALCOHOL ALOE VERA LEAF GLYCERIN CINNAMON LEAF OIL ROSEMARY OIL CLOVE OIL CINNAMON BARK OIL ORANGE OIL TERT-BUTYL ALCOHOL ALTHAEA OFFICINALIS ROOT CUCUMIS SATIVUS WHOLE 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 20 Count NDC: 71630-383-20 Single Packet: NDC 71630-383-11 NDC 71630-199-20 NDC 71630-383-11
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 and lasts.
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.Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at a temperature below 38 C (100 F).
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