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| Product NDC Code | 80254-000 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Skin block extra strength hand sanitizer |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1049254 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Charter Oak Development Corporation | ||||||||
| 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: Antiseptic Hand Sanitizer
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: Apply a small amount into palms and spread on both hands. Rub into skin until dry. Repeat as necessary.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Polyaminopropyl biguanide, 1-Octadecanaminum NN dimethyl (3- trimethoxysily) propyl chloride, C12-15 Pareth 12, Caprylyl Glucoside, Sodium Benzoate, Glycerin, Aloe Barbadensis Leaf Juice Extract, Citric Acid
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: Hand and skin anti-microbial to help decrease pathogens (bacteria & germs) on the skin. Recommended for repeated use
Purpose
Information about the drug product’s indications for use.Purpose: Antiseptic Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Skin Block Extra Strength Hand Sanitizer BENZALKONIUM CHLORIDE WATER POLYAMINOPROPYL BIGUANIDE CAPRYLYL GLUCOSIDE SODIUM BENZOATE GLYCERIN ALOE VERA LEAF CITRIC ACID MONOHYDRATE 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:50ml Bottle
Package Labeling:200ml Bottle2
Package Labeling: Bottle3
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 ears or mouth.
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. Children should be supervised when using this product.
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 redness or irritation develop and persist for more than 72 hours
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 the eyes. In case of contact, flush eyes with water.
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: Do not freeze For external use only Do not use in ears or mouth. When using this product, avoid contact with the eyes. In case of contact, flush eyes with water. Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours Keep out of reach of children. Children should be supervised when using this product.
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