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| Product NDC Code | 80638-150 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antibacterial antiseptic wet wipes |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CLOTH | ||||||
| Application Number | part333A | ||||||
| Labeler Name | FRESH CO COSMETICS SH.P.K. | ||||||
| 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(s) Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic
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 adults and children 2 years and over apply to hands wet hands thoroughly with product and allow it to dry children under 2 years ask a doctor before use Directions for use to dispense peel back front label slowly remove wipes. to reseal pouch firmly run thumb over the label. donot flush
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients deionised water, ceteary isononanoate,cetearyl alcohol, glyceryl stearate, glycerin, ceteareth-12, cetyl palmitate, phenoxyethanol, sodium benzoate, fragrance, citric acid, disodium EDTA
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.Use Decrease bacteria on skin. For use when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Antibacterial Wet Wipes
Spl product data elements
Usually a list of ingredients in a drug product.Antibacterial Antiseptic Wet Wipes Benzalkonium Chloride CETEARYL ISONONANOATE CETOSTEARYL ALCOHOL WATER BENZALKONIUM CHLORIDE BENZALKONIUM POLYOXYL 20 CETOSTEARYL ETHER SODIUM BENZOATE GLYCERYL MONOSTEARATE EDETATE DISODIUM CETYL PALMITATE CITRIC ACID MONOHYDRATE GLYCERIN CETEARETH-12 PHENOXYETHANOL
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 48 wet wipes NDC: 80638-150-48 102 wet wipes NDC: 80638-150-12 Wet wipes 48 wet wipes 102
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 children less than 2 months of age on open skin wounds
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 at 1800-222-1222.
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 ordevelops and continues for morethan 72 hours. These may be signs of a serious condition.
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 do not get into eyes, ears, and mouth. If contact occurs,rinse thoroughly with water. Stop use and ask a doctor if irritation or rash develops and continues for morethan 72 hours. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat
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