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Product NDC Code | 10819-3917 | ||||||
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Drug Name | Pdi sani-hands instant hand sanitizing wipes |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CLOTH | ||||||
RxCUI drug identifier | 1251416 | ||||||
Application Number | 505G(a)(3) | ||||||
Labeler Name | Professional Disposables International, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Alcohol 70% by volume
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 - To start feed: Remove cover and discard seal from container. From center of toweled roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at a 90 o angle. Keep cap closed to prevent evaporation. - Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry. - If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe. - Discard after single use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, glycerin, propylene glycol, purified water, tocopheryl 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 To decrease bacteria on the skin
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.PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol WATER PROPYLENE GLYCOL GLYCERIN ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE 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 front 135 ct back 135ct front 220 ct back 200 ct front 135 back 135 front back
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 Keep out of reach of children unless under adult supervision. 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 Lot No. and Expiration Date can be found on canister.
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. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water Do not use in or contact with eyes. Stop use and ask a doctor if irritation or redness develops and continues for more than 72 hours Discontinue use if irritation and redness develop. If condition for more persists for more than 72 hours, consult a doctor
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