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| Product NDC Code | 84488-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zehn antiseptic sanitizing wipes |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CLOTH | ||||||
| RxCUI drug identifier | 1038558 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Zehn-X LLC | ||||||
| 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 Benzalkonium Chloride 0.13 %
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 ■ Wet targeted area thoroughly with product and let dry without wiping.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Aloe Vera, Tea Tree (melaleuca alternifolia) Leaf Oil
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 germs and bacteria. ■ Safe and effective on skin. ■ For repeated use on targeted areas.
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.Zehn Antiseptic Sanitizing Wipes Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM ALOE VERA LEAF WATER MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
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.10 TOWELETTES NDC: 84488-001-01 10 Wipes Label
1200 WIPES NDC: 84488-001-02 1200 Wipes Label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ■ In the eyes
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if: ■ Irritation and redness develops ■ Condition persists for more than 72 hours
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ Store below 104˚F (40˚C) ■ May discolor certain fabrics
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.
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