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Product NDC Code | 77578-003 | ||||||
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Drug Name | Sanitizer |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 1039339 | ||||||
Application Number | part333A | ||||||
Labeler Name | Nutraze, S.C de R.L. de C.V. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Alcohol 80% 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.Topical
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, hydrogen peroxide, purifed 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(s) Hand Sanitizer Antiseptic solution to help reduce bateria that potentially can cause disease. For use when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Sanitizer Alcohol, citric acid HYDROGEN PEROXIDE WATER GLYCERIN ALCOHOL ALCOHOL
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.Principal Display Panel 500 mL NDC:77578-003-01 Sanybeda
Package Label- Principal Display Panel 1000 L NDC: 77578-003-02 Sanybeda
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.If irritation or rash occurs. These may be signs of a serious condition.
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.- In children less than 2 months of age - In open skin wounds
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.If swallowed, get medical help, or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information - Store between 15-30°C (59-86°F) - Avoid freezing and excessive heat above 40°C (104°F)
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.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.Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes 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 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