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Product NDC Code | 67777-010 | ||||||||||||||||
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Drug Name | Sannytize hand sanitizer |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||
Dosage Form | GEL | ||||||||||||||||
RxCUI drug identifier | 581662 | ||||||||||||||||
Application Number | M003 | ||||||||||||||||
Labeler Name | Dynarex Corporation | ||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alcohol 70%
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 Wet hands thoroughly with product and allow to dry without wiping
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Vera Leaf Extract, Carbopol Ultrez 10, Fragrance, Glycerin, Propylene Glycol, Purified Water,Triethanolamine
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 hand washing to decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Handwash
Spl product data elements
Usually a list of ingredients in a drug product.SannyTize Hand Sanitizer Hand Sanitizer ALOE VERA LEAF GLYCERIN TROLAMINE WATER PROPYLENE GLYCOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 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.Label 1428 Hand Sanitizer 1428-BX-GVIN010
Label 1427 Hand Sanitizer
Label 1427 Hand Sanitizer 1427-BX-GVIN010
Label 1429 Hand Sanitizer 1429-BX-GVIN010
Label 1431 Hand Sanitizer 1431- GVIN010
Label 1432 Hand Sanitizer 1432-GVIN010
Label 1433 Hand Sanitizer 1433-GVIN010
Label 1427 Hand Sanitizer 1427-BX-MASTER
Label 1428 Hand Sanitizer 1428-BX-MASTER
Label 1429 Hand Sanitizer 1429-BX-MASTER
Label 1431 Hand Sabitizer 1431-IN-MASTER
Labels 1432 Hand Sanitizer 1432-IN-MASTER
Label 1433 Hand Sanitizer 1433-BX-MASTER
Label 1433UB-10 1433UB-10 1433UB-10_BX_MASTER
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 the eyes.
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Do not store above 110°F (43ºC) May discolor some fabrics Recommended for repeated use
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-396-2739 Monday - Friday, 9AM - 5PM EST
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 and redness develop.
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 eyes. • In case of eye contact, rinse with water to remove
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 or flame Do not use In the eyes. When using this product • Avoid contact with eyes. • In case of eye contact, rinse with water to remove Stop use and ask a doctor if Irritation and redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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