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| Product NDC Code | 74712-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581660 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | In Designs Global LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Alcohol 62% 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 Rub dime sized amount between hands until dry. Supervise children in the use of this product. In the case of eye contact, rinse eyes thoroughly with water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aminomethyl Propanol, Carbomer, Water.
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 For handwashing to decrease bacteria on the skin
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.Hand Sanitizer ALCOHOL AMINOMETHYLPROPANOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER ALCOHOL ALCOHOL
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: Label3
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
Other information Store below 105 °F May discolor some fabrics.
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, contact a doctor or Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-369-4670
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 the eyes and mucous membranes In the case of eyes or mucous membranes contact, rinse area thoroughly with water In case of deep or punture wounds or serious burns, consult physician. If redness, irritation, swelling, or pain persists or increases or if infection occurs discontinue use and physician.
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 keep away from fire and flame Flammable, Does not contain grain alcohol; do not drink. If taken internally serious gastric disturbances will result. When using this product Avoid the eyes and mucous membranes In the case of eyes or mucous membranes contact, rinse area thoroughly with water In case of deep or punture wounds or serious burns, consult physician. If redness, irritation, swelling, or pain persists or increases or if infection occurs discontinue use and physician. Keep out of reach of children If swallowed, contact a doctor or 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