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Hand sanitizer - Medication Information

Product NDC Code 77556-580
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 80 ml/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1039339
Application Number M003
Labeler Name Astera International LLC
Packages
Package NDC Code Description
77556-580-01 30 ml in 1 bottle (77556-580-01)
77556-580-02 59 ml in 1 bottle (77556-580-02)
77556-580-04 118 ml in 1 bottle (77556-580-04)
77556-580-08 236 ml in 1 bottle (77556-580-08)
77556-580-12 354 ml in 1 bottle (77556-580-12)
77556-580-13 400 ml in 1 bottle (77556-580-13)
77556-580-16 473 ml in 1 bottle (77556-580-16)
77556-580-32 946 ml in 1 bottle (77556-580-32)
77556-580-33 1000 ml in 1 bottle (77556-580-33)
77556-580-67 2000 ml in 1 bottle (77556-580-67)
77556-580-93 3785 ml in 1 bottle (77556-580-93)
77556-580-94 18927 ml in 1 container (77556-580-94)
77556-580-95 208198 ml in 1 drum (77556-580-95)
77556-580-97 1040990 ml in 1 tank (77556-580-97)
77556-580-99 1249190 ml in 1 tank (77556-580-99)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Alcohol 80% v/v. 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 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 glycerin, hydrogen peroxide, purified water USP

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 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, Hand Sanitizer

Spl product data elements

Usually a list of ingredients in a drug product.
Hand Sanitizer ALCOHOL GLYCERIN HYDROGEN PEROXIDE 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.
118 ML NDC: 77556-580-04 118 ML Hand Sanitizer 118 ML Hand Rub 59 ML NDC: 77556-580-02 59 ML Hand Rub 59 ML Hand Sanitizer 236 ML NDC: 77556-580-08 236 Hand Rub 236 Had Sanitizer 354 ML NDC: 77556-580-12 354 Hand Rub 354 ML Hand Sanitizer 400 ML NDC: 77556-580-13 400 ML Hand Rub 400 ML Hand Sanitizer 473 ML NDC: 77556-580-16 473 ML Hand Rub 473 ML Hand Sanitizer 946 ML NDC: 77556-580-32 946 ML Hand Rub 946 ML Hand Sanitizer 1000 ML NDC: 77556-580-33 1000 ML Hand Sanitizer 1000 ML Hand Rub 2000 ML NDC: 77556-580-67 2000 ML Hand Sanitizer 2000 ML Hand Rub 30 ML NDC: 77556-580-01 77556-580-01 1 oz hand sanitizer 77556-580-01 1 oz hand rub 3785 ML NDC: 77556-580-93 77556-580-93 128 oz hand sanitizer 77556-580-93 128 oz hand rub 18927 ML NDC: 77556-580-94 77556-580-94 640 oz hand sanitizer 77556-580-94 640 oz hand rub 208198 ML NDC: 77556-580-95 77556-580-95 7040 oz hand sanitizer 77556-580-95 7040 oz hand rub 1040990 ML NDC: 77556-580-97 77556-580-97 35200 oz hand sanitizer 77556-580-97 35200 oz hand rub 1249190 ML NDC: 77556-580-99 77556-580-99 42240 oz hand sanitizer 77556-580-99 42240 oz hand rub

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.
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

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.

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 use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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