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| Product NDC Code | 74683-2001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 581662, 1241663, 1489307 |
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| Application Number | part333A | ||||||
| Labeler Name | Horizon Tool Inc. | ||||||
| Packages |
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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.E2 hand wash E2 Sanitizing Hand Soap COCAMIDOPROPYL BETAINE WATER ANHYDROUS CITRIC ACID METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE SODIUM LAURETH SULFATE BENZALKONIUM CHLORIDE BENZALKONIUM SODIUM CHLORIDE SODIUM LAURYL SULFATE COCO DIETHANOLAMIDE E2 hand wash E2 Sanitizing Hand Soap COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE SODIUM CHLORIDE SODIUM LAURYL SULFATE WATER SODIUM LAURETH SULFATE BENZALKONIUM CHLORIDE BENZALKONIUM ANHYDROUS CITRIC ACID Hand Sanitizer ALOCOHL HYDROGEN PEROXIDE WATER ALCOHOL ALCOHOL GLYCERIN Hand Sanitizer ALCOHOL WATER RAPIDGEL EZ1 FRAGRANCE CLEAN ORC0600327 DENATONIUM BENZOATE ANHYDROUS ALCOHOL ALCOHOL GLYCERIN Hand Sanitizer ALCOHOL GLYCERIN HYDROGEN PEROXIDE ALCOHOL ALCOHOL WATER Hand Sanitizer ALCOHOL HYDROGEN PEROXIDE ALCOHOL ALCOHOL WATER GLYCERIN Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL HYDROGEN PEROXIDE GLYCERIN WATER Hand Sanitizer ALCOHOL WATER ALCOHOL ALCOHOL GLYCERIN HYDROGEN PEROXIDE Hand Sanitizer Wipes ALCOHOL GLYCERIN HYDROGEN PEROXIDE FRAGRANCE CLEAN ORC0600327 WATER ALCOHOL ALCOHOL Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL WATER HYDROGEN PEROXIDE GLYCERIN Hand Sanitizer ALCOHOL WATER FRAGRANCE CLEAN ORC0600327 RAPIDGEL EZ1 ALCOHOL ALCOHOL GLYCERIN Hand Sanitizer ALCOHOL FRAGRANCE CLEAN ORC0600327 RAPIDGEL EZ1 GLYCERIN DENATONIUM BENZOATE ANHYDROUS ALCOHOL ALCOHOL WATER Hand Sanitizer ALCOHOL WATER HYDROGEN PEROXIDE ALCOHOL ALCOHOL GLYCERIN
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 3785.41 mL NDC: 74683-2001-2 473 mL NDC: 74683-2001-1 118 mL NDC: 74683-5001-4 250 mL NDC: 74683-5001-3 59 mL NDC: 74683-5001-2 473 mL NDC: 74683-5001-1 250 mL NDC: 74683-1002-1 3785.4 mL NDC: 74683-6200-3 250 mL NDC: 7463-6200-2 3785.4 mL NDC: 74683-6200-1 3785.4 mL NDC: 74683-6000-1 59 mL NDC: 74683-2100-1 946.35 mL NDC: 74683-3001-1 262 mL NDC: 74683-2500-1 1892.71 mL NDC: 74683-5000-9 208.2 L NDC: 74683-5000-8 946.35 mL NDC: 74683-5000-7 946.35 mL NDC: 74683-5000-7 473 mL NDC: 74683-5000-6 3785.41 mL NDC: 74683-5000-5 3785.41 mL NDC: 74683-5000-4 354.8 mL NDC: 74683-5000-3 236 mL NDC: 74683-5000-2 118 mL NDC: 74683-5000-1 118 mL NDC: 74683-4000-1 3 mL NDC 74683-3000-8 3 mL NDC 74683-3000-8 3 mL NDC 74683-3000-9 3 mL NDC 74683-3000-9 3785.41 mL NDC 74683-3000-7 3785.41 mL NDC 74683-3000-6 3785.41 mL NDC 74683-3000-5 1892.71 mL NDC 74683-3000-4 946.35 mL NDC 74683-3000-3 946.35 mL NDC 74683-3000-3 118 mL NDC 74683-3000-2 59 mL NDC 74683-3000-1 59 mL NDC 74683-3000-1 473 mL NDC 74683-1000-9 236 mL NDC 74683-1000-8 059 mL NDC: 74683-1000-6 059 mL NDC: 74683-1000-6 74683-1000-7 236 mL NDC: 74683-2000-1 473 mL NDC: 74683-1000-2 946.35 mL NDC: 74683-1000-3 946.35 mL NDC: 74683-1000-3 1892.71 mL NDC: 74683-1000-4 3785.41 mL NDC: 74683-1000-5 473 mL NDC: 74683-2000-1 473 mL NDC: 74683-2000-1 946.35 mL NDC: 74683-2000-2 946.35 mL NDC: 74683-2000-2 1892.71 mL NDC: 74683-2000-3 3785.41 mL NDC: 74683-2000-4 3785.41 mL label 473 mL front label 473 mL rear label 118 mL label 250 mL label 59mL Label 473 mL label 250 mL label 3785.4 mL label 250 mL label 3785.4 mL label 3785.4 mL label 59ml label 946.35 ml label 262 mL wipe label 1892.71 mL label 208.2 L label 946.35 mL rear label 946.35 mL front label 473 mL label 3785.41 mL 4cc label 3785.41 mL 10cc label 354.8 mL label 236 mL label 118 mL label 118 mL Tiger gel label 3mL gel rear 3mL gel front 3mL gel rear 3mL gel front 3785.41mL gel 3785.41mL gel 3785.41mL gel 1892.71mL gel 946.35mL gel rear 946.35mL gel front 118mL gel 59mL gel rear 59mL gel front 473mL gel TenSan 236mL gel TenSan 59 mL gel front 59 mL gel rear 118 mL gel 236mL gel 473mL gel 946.35 mL front label 946.35mL gel rear 1892.71mL gel 3785.41mL gel 473mL liquid front 473mL liquid rear 946.35mL liquid front 946.35mL liquid rear 1892.71mL liquid 3785.41mL liquid
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