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Product NDC Code | 57660-004 | ||||
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Drug Name | Coconut foaming hand sanitizer with natural vitamin e and almond oil |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1046310 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | TJA Health LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Benzalkonium Chloride 0.12% PURPOSE Antimicrobial
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 Apply to dry hands, rub together, & let dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Purified water, surfactant, vitamin E(natural, d-alpha tocopherol), almond oil (natural), polysorbate 20, isopropyl alcohol USP, natural essential oil complex, natutal coconut scent.
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 hand sanitizing to decrease bacteria on the skin Recommended for repeated use
Purpose
Information about the drug product’s indications for use.PURPOSE Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Coconut Foaming Hand Sanitizer With Natural Vitamin E and Almond Oil BENZALKONIUM CHLORIDE WATER .ALPHA.-TOCOPHEROL ALMOND OIL POLYSORBATE 20 BENZALKONIUM CHLORIDE BENZALKONIUM DIHYDROXYETHYL COCAMINE OXIDE ACETAMIDOETHOXYETHANOL COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
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.Package Labeling: 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 2 years of age and younger. If swallowed, get help or contact a Poison Control Center right away.
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. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs. Keep out of reach of children 2 years of age and younger. If swallowed, get 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