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Antiseptic hand sanitizer - Medication Information

Product NDC Code 76138-113
Drug Name

Antiseptic hand sanitizer

Type Brand
Active Ingredients
Alcohol 62 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581660
Application Number 505G(a)(3)
Labeler Name Innovation Specialties Inc
Packages
Package NDC Code Description
76138-113-03 30 ml in 1 bottle (76138-113-03)
76138-113-07 53 ml in 1 bottle (76138-113-07)
76138-113-01 59 ml in 1 bottle (76138-113-01)
76138-113-16 1 bottle in 1 bag (76138-113-16) / 15 ml in 1 bottle
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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 Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, 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.
Use For handwashing 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.
ANTISEPTIC HAND SANITIZER Ethyl Alcohol CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE 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.
Packaging sanitizer-6

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 Made in China for Innovation Line Culver City, CA 90230

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? HOTLINE # 1-855-755-5346

Storage and handling

Information about safe storage and handling of the drug product.
Store at room temperature 15 0 to 30 0 C (59 0 to 86 0 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.
Warnings Flammable, keep away from fire or flame. For external use only. Do not use in the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation and redness develop and persist for 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