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| Product NDC Code | 82127-004 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mandarin orange scented antiseptic hand sanitizer 80 ethyl alcohol |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1241663 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | H&Y Products LLC dba Kolonya Carre | ||||||
| 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 80% Purpose Antiseptic
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Fragrance, Alpha isomethyl ionone, Benzyl salicylate, Butylphenyl methylpropional, Citral, Citronellol, Coumarin, Limonene, Linalool
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 washing 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.Mandarin Orange Scented Antiseptic Hand Sanitizer 80 Ethyl Alcohol ALCOHOL WATER ISOMETHYL-.ALPHA.-IONONE BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL CITRAL .BETA.-CITRONELLOL, (R)- COUMARIN LIMONENE, (+)- LINALOOL, (+/-)- 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.Package Labeling:82127-004-01 Outer Package9 Inner Package9
Package Labeling:82127-004-02 Outer Package10 Inner Package10
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
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 a doctor if irritation and redness develop. condition 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 Stop use and ask a doctor if 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