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Product NDC Code | 58575-183 | ||||||
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Drug Name | Choice hand sanitize |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
RxCUI drug identifier | 581662 | ||||||
Application Number | part333E | ||||||
Labeler Name | Inopak. Ltd | ||||||
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.Administration Directions Apply sufficient amount of product to your palm to cover both hands. Rub until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, 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.Usage Uses To decrease bacteria on the skin that potentially can cause disease Recommended for repeated use
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.Choice Hand Sanitize Ethyl Alcohol ALOE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ISOPROPYL ALCOHOL PEG/PPG-18/18 DIMETHICONE WATER 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.Choice Box Container Drug Facts Active Ingredient Purpose Ethyl Alcohol 70% v/v ……………Antiseptic Uses To decrease bacteria on the skin that potentially can cause disease Recommended for repeated use Warnings Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if 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. Children should be supervised by an adult when using this product. Directions Apply sufficient amount of product to your palm to cover both hands. Rub until dry. Other Information May discolor certain fabrics and surfaces. Inactive Ingredients Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water Choice HAND SANITIZING GEL Aloe Ver And Vitamin E Instant Waterless Contains Moisturizers PN 5025-404UV-CH 800m Hand sanitizing gel Contains Aloe Vera and Vitamin E Instant waterless with moisturizers Produced in an FDA registered facility cGMP facility Dries quickly leaving the skin feeling soothed and moisturized Kills 99.9% of Germs MADE IN THE USA Choice Dispenser Loading Instructions Section 1 Section 2 Section 3 Section 4 Section 1 Section 2 Section 3 Section 4 Choice Box
Choice Case 5025-CH-CS Rev. 1.0 Choice™ HAND SANITIZING GEL Kills 99.9% of Germs Instant Waterless Aloe Ver and Vitamin E Contains Moisturizers MADE IN THE USA 5025-404UV-CH 12/800 ML UV 040232 65077 2 Choice Case
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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 Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water May discolor certain fabrics and surfaces.
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 Usage Stop use and ask a doctor if irritation and redness develop or if 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 Warnings Flammable, keep away from heat or flame. For external use only.
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