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| Product NDC Code | 79539-601 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Instant hand sanitizeing wipe |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | CLOTH | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 2553300 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number | M003 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | Shandong Yayun Sanitary Products Co., Ltd. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Benzalkonium Chloride 0.05% w/w. 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 Wipe the surface of the skin and let it dry naturally. Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Propylene Glycol Aqua Phenoxyethanol Glycerin Aloe Barbadensis leaf Extractt Disodium EDTA Getylpyridinium Chloride Sodium Citrate TocopherylAcetate Tea tree oil Perfum
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 Instant Hand Sanitizeing Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.Instant Hand Sanitizeing Wipe BENZALKONIUM CHLORIDE EDETATE DISODIUM ANHYDROUS CHLORIDE ION BENZALKONIUM CHLORIDE BENZALKONIUM .ALPHA.-TOCOPHEROL ACETATE PROPYLENE GLYCOL GLYCERIN PHENOXYETHANOL WATER CANANGA ODORATA LEAF OIL ALOE VERA LEAF SODIUM CITRATE TEA TREE 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.Package Label - Principal Display Panel label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Instant Hand Sanitizeing Wipe
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.
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 or rash occurs. 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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. 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.
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 above 40C (104F)
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