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| Product NDC Code | 72513-200 | ||||||||||||||||
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| Drug Name | 8hd hand and skin sanitizer |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||
| RxCUI drug identifier | 1049254 | ||||||||||||||||
| Application Number | M016 | ||||||||||||||||
| Labeler Name | Strategia Project Management, Inc. | ||||||||||||||||
| 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% PURPOSE Antimicrobial
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: On dry hands, place enough product in your palms to thoroughly cover the targeted area. Rub briskly until entirely dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Hydrated Silica Complex
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: Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.
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.8HD Hand and Skin Sanitizer BENZALKONIUM CHLORIDE HYDRATED SILICA WATER BENZALKONIUM CHLORIDE BENZALKONIUM
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 Labeling:72513-200-01 1oz 72513-200-01
Package Labeling:72513-200-02 2oz 72513-200-02
Package Labeling:72513-200-03 1L 72513-200-03
Package Labeling:72513-200-04 1Gal 72513-200-04
Package Labeling:72513-200-05 55Gal 72513-200-05
Package Labeling:72513-200-06 275Gal 72513-200-06
Package Labeling:72513-200-07 330Gal 72513-200-07
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.DRUG FACTS
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 eyes. If contact occurs, flush thoroughly with water.
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.
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 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 in eyes. If contact occurs, flush thoroughly 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 reach of children: If swallowed, get medical help or contact a Poison Control Center.
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