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Product NDC Code | 10819-6007 | ||||
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Drug Name | Sani professional hands instant sanitizing wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
RxCUI drug identifier | 1489307 | ||||
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 Ethyl 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 Canister: to dispense, lift cover, remove seal, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep cap closed to prevent moisture loss. use entire wipe to thoroughly wipe hands, fingers, and wrists for dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe discard after single use Packet: open packet use entire wipe to thoroughly wipe hands, fingers, and wrists to sanitize, use multiple wipes 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.Sani Professional Hands Instant Sanitizing Wipes Alcohol GLYCERIN WATER ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE PROPYLENE GLYCOL ALCOHOL ALCOHOL Sani Professional Hands Instant Sanitizing Wipes Alcohol ALOE VERA LEAF ALCOHOL ALCOHOL WATER ALPHA-TOCOPHEROL ACETATE PROPYLENE GLYCOL GLYCERIN Sani Professional Hands Instant Sanitizing Wipes Alcohol ALPHA-TOCOPHEROL ACETATE ALCOHOL ALCOHOL WATER ALOE VERA LEAF PROPYLENE GLYCOL 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.Principal display panel Packet Canister, 150ct Canister, 300ct packet front back front 300 back 300
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
Storage and handling
Information about safe storage and handling of the drug product.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 Discontinue use if irritation and redness develop. If condition 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