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Product NDC Code | 83930-010 | ||||
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Drug Name | Medi wiper hand sanitizing wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1038856 | ||||
Application Number | M003 | ||||
Labeler Name | TIMK, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Benzalkonium Chloride 0.1%
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 ■ Clean with wipes and let dry ■ Do not flush
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Phenoxyethanol, Glycerin, Sodium Benzoate, Polysorbate20, Disodium EDTA, Tocopheryl Acetate, Citric Acid
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 Instant hand antiseptic 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.Medi wiper Hand Sanitizing Wipes Benzalkonium Chloride Benzalkonium Chloride BENZALKONIUM Water Phenoxyethanol Glycerin Sodium Benzoate Polysorbate 20 EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE CITRIC ACID MONOHYDRATE
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 LABEL.PRINCIPAL DISPLAY PANEL Image of container
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Read the directions and warnings before use ■ Avoid freezing and excessive heat above 40 degree C (104 degree F)
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 ------------------------------------------------------------------------------ Stop use and ask a doctor if ■ hypersensitivity symptoms such as erythema, itching and dermatitis happen ■ skin irritation happens ------------------------------------------------------------------------------ Do not use ■ in combination with soap or antibacterial cleansing agents ■ the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin ------------------------------------------------------------------------------- When using this product ■ aviod using repeatedly in the same area, skin irritation may occur ■ avoid getting into the eyes (if contact occurs, wash well with clean water) ■ if following abnormal symptoms persist, discontinue use : Irritation around the eyes, ears, mucous membranes, including the mouth, skin irritation and rashes ------------------------------------------------------------------------------- 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