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Product NDC Code | 78828-222 | ||||
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Drug Name | Loews hotels antiseptic hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1305100 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Carretta USA, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl alcohol 75% 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 • wet hands thoroughly with product and allow to dry without wiping • for children under 6 years of age , use only under adult supervision
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Extract, Arginine, Carbomer 940, 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 hand sanitizing 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.LOEWS HOTELS Antiseptic Hand Sanitizer Ethyl alcohol ALCOHOL ALCOHOL ALOE ARGININE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER
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.Packaging HandSanitizer-222
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
Distributed by: Carretta USA, Inc., 16 Rutherford Rd. Unit 246, Allamuchy, NJ 07820 Made in China Peel corner for full Drug Facts label You may report serious side effects to Carretta USA,Inc., 16 Rutherford Rd. Unit 246,Allamuchy, NJ 07820
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 20°C to 25°C (68° to 77°F) • may discolor fabrics
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 Flammable, keep away from fire or flame For external use only Do not use • in the eyes. In case of contact with eyes, flush thoroughly with water • in children under 2 years of age When using this product • avoid contact with broken skin • do not inhale or ingest Stop use and ask a doctor if • skin irritation and redness develop • condition 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