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| Product NDC Code | 61010-3111 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antimicrobial |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LIQUID | ||||||||||
| RxCUI drug identifier | 1087912 | ||||||||||
| Application Number | 505G(a)(3) | ||||||||||
| Labeler Name | Safetec of America, Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 66.5%
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 and wrists thoroughly for 15 seconds and allow to air dry always reseal after use children under 6 years of age should be supervised when using this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe vera, fragrance, purified water, triethanolamine SAFETEC OF AMERICA, Inc. 887 Kensington Ave. Buffalo, NY 14215 800-456-7077 www.safetec.com Reorder no. 34409 275 Gal. (1,041 L)
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 is not readily available
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.Antimicrobial alcohol ALOE 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 – 275 Gallon Container Label NDC 61010-3111-4 Safetec p.a.w.s. Antimicrobial Liquid Kills 99.9% of Germs! Contains 66.5% Ethyl Alcohol Enriched with Aloe Vera Fresh Scent Drug Facts Active Ingredient Purpose Ethyl Alcohol 66.5% Antiseptic Uses for handwashing to decrease bacteria on skin whenever soap and water is not readily available Warnings For external use only. Flammable, keep away from fire or flame Do not use in the eyes. If this happens, rinse thoroughly with water. Stop use and ask doctor if irritation or 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 Directions wet hands and wrists thoroughly for 15 seconds and allow to air dry always reseal after use children under 6 years of age should be supervised when using this product Inactive ingredients Aloe vera, fragrance, purified water, triethanolamine SAFETEC OF AMERICA, Inc. 887 Kensington Ave. Buffalo, NY 14215 800-456-7077 www.safetec.com Reorder no. 34409 275 Gal. (1,041 L) PRINCIPAL DISPLAY PANEL – 275 Gallon 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
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. If this happens, rinse thoroughly with water.
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 or redness develop and persists for more than 72 hours
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. If this happens, rinse thoroughly with water. Stop use and ask doctor if irritation or 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