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| Product NDC Code | 61354-038 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | part333A | ||||
| Labeler Name | Oxygen Development 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 Alcohol 70%
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 Put enough product in your palm to cover hands & rub hands together until dry. Children under 6 years of age should be supervised when using this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua, Glycerin, Fragrance, Polysorbate 20, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice
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.When using this product When using this product do not use in or near the eyes. in case of contact, rinse eyes troroughly with water.
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.Hand Sanitizer Alcohol GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER ALCOHOL ALCOHOL FRAGRANCE 13576 POLYSORBATE 20
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 61354-038-01_AW
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 doctor Stop use and ask doctor if irritation or rash persists.
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.Use For handwashing to decrease bacteria on the skin.
Storage and handling
Information about safe storage and handling of the drug product.Other Information store below 110 F (43 C). May discolor certain fabric surfaces.
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 Do not eat or drink. Topical application only. Flammable. Keep away from fire or flame. 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