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Optimize thick hand sanitizer - Medication Information

Product NDC Code 68400-486
Drug Name

Optimize thick hand sanitizer

Type Brand
Active Ingredients
Alcohol 70 ml/100ml
Route TOPICAL
Dosage Form GEL
Application Number part333A
Labeler Name Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Packages
Package NDC Code Description
68400-486-15 473.2 ml in 1 bottle, plastic (68400-486-15)
68400-486-06 177.4 ml in 1 bottle, plastic (68400-486-06)
68400-486-16 473.2 ml in 1 bottle, plastic (68400-486-16)
68400-486-08 236.6 ml in 1 bottle, plastic (68400-486-08)
68400-486-01 3780 ml in 1 bottle, plastic (68400-486-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient 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.
Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, glycerin, isopropyl myristate, carbomer, tocopheryl acetate, triethanolamine

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(s) Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.
Optimize Thick Hand Sanitizer ALCOHOL GLYCERIN WATER ISOPROPYL MYRISTATE TROLAMINE .ALPHA.-TOCOPHEROL ACETATE ALCOHOL ALCOHOL CARBOMER HOMOPOLYMER TYPE C

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 Label - Principal Display Panel Keystone_HandSanitizer_16oz_4916655

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use in children less than 2 months of age on open skin wounds

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.

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, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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 heat or flame Do not use in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children . If swallowed, get medical help or contact 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