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Antibacterial hand sanitizer - Medication Information

Product NDC Code 70412-134
Drug Name

Antibacterial hand sanitizer

Type Brand
Active Ingredients
Alcohol 620 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581660
Application Number 505G(a)(3)
Labeler Name Zhejiang Ayan Biotech Co.,Ltd.
Packages
Package NDC Code Description
70412-134-15 15 ml in 1 bottle (70412-134-15)
70412-134-30 30 ml in 1 bottle (70412-134-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Ethyl Alcohol 62% 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. • For children under 6 age use only under adult supervision. • Not recommended for infants.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Carborner, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water. Red 4 (CI 14700), Red 33 (CI 17200)

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.
Uses • For Hand Sanitizing

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.
Antibacterial Hand Sanitizer ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER FD&C RED NO. 4 D&C RED NO. 33 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: 70412-134-15 Label7 Package Labeling: 70412-134-30 Label8

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 Other Information • Do not store above 105°F. • May discolor some fabrics.

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 call a Poison Control Center right away.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

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-hands. Flammable. Keep away from heat and flame. When using this product Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Keep out of reach of children. If swallowed, get medical help or call 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