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| Product NDC Code | 81551-802 | ||||
|---|---|---|---|---|---|
| Drug Name | Novo foaming instant hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 616805 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Noble Chemical Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.active ingredient Ethyl Alcohol 70% 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.dosage Apply liberally to hands to cover all surfaces Rub hands together until dry Supervise children under 6 years old Not recommended for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Aloe Barbadensis leaf Juice, D&C Green #5, Fragrance, PEG-10 acrylate/perfluorohextl acrylate copolymer, Perfluorohexylethyl alcohol, Propylene Glycol, 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.Indications To decrease bacteria on hands when changing diapers,assiting ill persons or before contact with a person under medical care or treatment Recommended for repeated use Use this product when soap and water are not available
Purpose
Information about the drug product’s indications for use.puepose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Novo Foaming Instant Hand Sanitizer ethyl alcohol DIMETHICONE PEG-8 LAURATE WATER EDETOL FRAGRANCE LEMON ORC2001060 GLYCERIN ALCOHOL ALCOHOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALOE VERA LEAF
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.label label
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 Keep out of reach of children. If swallowed get medical help or contact poison control center immediately.
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 When using product avoid contact with eyes. In case of eye contact, rinse eyes with water Stop use and ask doctor if irritation or redness develop or last more than 72 hours
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