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Product NDC Code | 53603-1048 | ||||
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Drug Name | Instant hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 581660 | ||||
Application Number | part333E | ||||
Labeler Name | BB17, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Ethyl Alcohol 62%
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: Rub into hands until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Olive Oil, Fragrance, Carbomer, Triethanolamine, D&C Red No.33.
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.KILLS MORE THAN 99.99% OF COMMON GERMS
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.instant hand sanitizer ETHYL ALCOHOL ALCOHOL ALCOHOL WATER ALOE VERA LEAF GLYCERIN PROPYLENE GLYCOL CARBOMER INTERPOLYMER TYPE A (55000 CPS) TROLAMINE D&C RED NO. 33 OLIVE OIL
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.image of bottle 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 OF CHILDREN.
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.DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP. IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR OR PHYSICIAN.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store below 110 F.
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.WARNING: FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. FOR EXTERNAL USE ONLY.DO NOT USE IN THE EYES.
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