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| Product NDC Code | 80773-003 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sopure 80% ethanol sanitizing wipes |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CLOTH | ||||||||||
| RxCUI drug identifier | 2361646 | ||||||||||
| Application Number | M003 | ||||||||||
| Labeler Name | EnviroServe Chemicals & Cleaners Ltd. | ||||||||||
| 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 Ethanol 80% Purpose Medicated Skin Cleanser Kills harmful bacteria/germs
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 Use as need on basis. Wipe your hands to help prevent spread of bacteria.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Water, glycerin, hydrogen peroxide, alpha tocopherol acetate
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 Hand Sanitizing wipes Kills harmful bacteria/germs.
Purpose
Information about the drug product’s indications for use.Purpose Medicated Skin Cleanser Kills harmful bacteria/germs
Spl product data elements
Usually a list of ingredients in a drug product.SOPURE 80% Ethanol Sanitizing wipes Ethanol WATER ALCOHOL ALCOHOL HYDROGEN PEROXIDE .ALPHA.-TOCOPHEROL ACETATE GLYCERIN
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 Labeling: SoPure 80 Wipes SoPure 100 Wipes SoPure 120 wipes SoPure 160 Wipes Label Label Label Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information keep Packet tightly closed and stored at room temperature hold away from face when opening
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.Ask a doctor before use if you have deep or puncture wounds animal bites serious burns
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? [email protected]
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 do not get in eyes
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 fire or flame, heat, spark, electrical Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water. If irritation develops, consult a doctor. Keep out of reach of children. Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician). If swallowed, call a poison control center or get medical help right away. Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not get in eyes Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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