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| Product NDC Code | 51326-900 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanix alcohol hand rub |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 581660 | ||||
| Application Number | M003 | ||||
| Labeler Name | Topiderm, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Ethyl Alcohol 62% (v/v)
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 enough product into the palm and rub hands together to thoroughly wet them Continue until the product dries without wiping off Supervise children when they are using the product Store below 110°F (43°C) May discolor some types of fabrics & surfaces.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Aloe Barbadensis Leaf Juice, Glycerin, Tocopheryl Acetate, Polysorbate 20, Isopropyl Alcohol, Isopropyl Palmitate, Tetrahydroxypropyl Ethylenediamine, Carbomer, Fragrance.
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 sanitizer for reduction of bacteria on the skin.
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.Sanix Alcohol Hand Rub Alcohol ALCOHOL ALCOHOL ISOPROPYL PALMITATE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER EDETOL ISOPROPYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 20 GLYCERIN
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 - 237 ml Bottle Label ANTIBACTERIAL Hand Sanitizer Gel by REPLENIX ® Kills 99.9% of Most Illness Causing Germs* Triple Action Moisturizers Softens Hands with Aloe, Vitamin E & Glycerin Made in USA Trusted By MEDICAL PROFESSIONALS Manufactured by Topix Pharmaceuticals Net 8 fl.oz. (237ml) PRINCIPAL DISPLAY PANEL - 237 ml Bottle 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.Drug Facts
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. Not for use on infants. If product is swallowed, get medical help or contact a Poison Control Center immediately.
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 appears and lasts.
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. Flammable. Keep away from fire and flame. Keep out of and away from the eyes. In case of eye contact flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. Not for use on infants. If product is swallowed, get medical help or contact a Poison Control Center immediately.
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