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Product NDC Code | 82355-551 | ||||
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Drug Name | Benzalkonium chloride |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
Application Number | part333A | ||||
Labeler Name | ALO NEW YORK LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients 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 adults and children 2 years and over: apply to hands: allow to dry without wiping children under 2 years: ask a doctor before use. To dispense : Peel back fron label slowly. Remove wipes. To reseal : Firmly rub thumb over label. Dispose of wipe in trash. Do not flush.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Purified Water, Decyl Glucoside, Aloe Barbadensis (Aloe) Leaf Extract, Phenoxyethanol, Citric Acid, Sodium Benzoate, Potassium Sorbate, Eucalyptus Globulus Oil, Mentha Piperita (Peppermint) 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 for hand sanitizing to decrease bacteria on the skin recommended for repeated use
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Benzalkonium Chloride Sanitizing Hand Wipes WATER ALOE VERA LEAF PHENOXYETHANOL SODIUM BENZOATE DECYL GLUCOSIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE BENZALKONIUM CHLORIDE BENZALKONIUM BERGAMOT OIL ORANGE 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.Principal Display Panel ALO 20 Skin-Softening Sanitizing Hand Wipes Sweet Orange Bergamot
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 if you are allergic to any of these ingredients.
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 the reach of children. If swallowed, get medical help or contact 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 store below 95 store below 95°F (35°C). keep closed tightly may discolor certain fabrics or surfaces.
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 avoid contact with eyes. In case of contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
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. Do not use if you are allergic to any of these ingredients. When using this product avoid contact with eyes. In case of contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of the reach of children. If swallowed, get medical help or contact 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