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Product NDC Code | 52854-600 | ||||||||||||||
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Drug Name | Hand sanitizer |
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Type | Brand | ||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||
Dosage Form | LIQUID | ||||||||||||||
RxCUI drug identifier | 2468410 | ||||||||||||||
Application Number | M003 | ||||||||||||||
Labeler Name | Tropical Seas, Inc. | ||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Ethyl Alcohol 64.325%
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 rinse solids & slime from hands if possible. pat dry. put a thumbnail size amount in your palm and rub hands together briskly until dry. repeat as needed. children under 6 months: As a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients deionized water, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, and fragrance.
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 sanitizing hands to help reduce bacteria on the skin. for deodorizing hands to help reduce odors 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 SDA 40B Alcohol 200 Proof ALCOHOL ALCOHOL AMINOMETHYLPROPANOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE 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.Principal Display Panel - Bottle Label 60ml NDC: 52854-600-01 119ml NDC: 52854-600-02 237ml NDC: 52854-600-03 250ml NDC: 52854-600-04 1000ml NDC: 52854-600-05 3785ml NDC: 52854-600-06 60ml label 119ml label 237ml label 250ml label 1000ml label 3785ml 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 Drug Facts
Other Information Warning: Flammable do not use near open flame or heat source do not store above 110°F (43°C) protect this product from excessive heat and direct sun may discolor certain fabrics or surfaces
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 on damaged or broken skin
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call toll free1-800-368-7327
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 rash occurs
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 keep out of eyes. 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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is 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