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| Product NDC Code | 78405-001 | ||||
|---|---|---|---|---|---|
| Drug Name | 75 alcohol antiseptic wipes |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1307051 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | WATERMARK LIMITED | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each wipe) Alcohol 75% Purpose Antimicrobial
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 Open clip-lid and peel back fresh-seal label. Remove moist towels to clean skin as required. Responsibly discard towel once used. Do not flush. Close lid when not in use to keep remaining towels moist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/aqua 24.8%, Glycerin 0.2%.
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 For sanitizing skin. Suitable for hygienic personal care and disinfectant cleansing within private spaces.
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.75 Alcohol Antiseptic Wipes ALCOHOL 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.Package Labeling: Bottle
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
Store in a cool dry place and keep away from heat and direct sunlight.
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 Poison Control right away.
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 in eyes, flush thoroughly with water. In the event of an adverse reaction discontinue use and contact a doctor.
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 When using this product avoid contact with eyes. If in eyes, flush thoroughly with water. In the event of an adverse reaction discontinue use and contact a doctor. Keep out of reach of children. If swallowed, get medical help or contact Poison Control 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