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| Product NDC Code | 61010-4111 | ||||
|---|---|---|---|---|---|
| Drug Name | Instant 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 | 505G(a)(3) | ||||
| Labeler Name | Safetec of America, 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 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 place a small amount into one hand spread over both hands and wrist rub into the skin until dry do not wipe off; no rinsing required
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com
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 for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection recommended for repeated use
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.Instant Hand Sanitizer alcohol ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) D&C GREEN NO. 5 D&C YELLOW NO. 10 WATER TROLAMINE 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.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label NDC 61010-4111-1 Safetec instant Hand Sanitizer Kills 99.9% of Germs Enriched with Aloe Vera Fresh 34,688 fl.oz. (1,026 L) Reorder No. 17392 PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container 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. If swallowed, get medical help or contact a Poison Control Center right away
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 doctor if irritation and redness develop and persists 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 do not get into eyes. If contact occurs, rinse eyes thoroughly 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 For external use only. Flammable, keep away from fire or flame When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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