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| Product NDC Code | 81630-003 | ||||||||||||||
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| Drug Name | Wash-free surgical hand disinfectant gel ii |
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| Type | Brand | ||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | GEL | ||||||||||||||
| RxCUI drug identifier | 1305100 | ||||||||||||||
| Application Number | part333A | ||||||||||||||
| Labeler Name | Shan Dong Lircon Medical Technology Co., Ltd | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Major ingredient and concentration This product is a disinfectant gel with ethanol as the main active ingredient, and the ethanol content is 75%±7.5% v/v. Add skin care ingredients such as moisturizers and moisturizers.
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.Usage Sanitary hand disinfection: Take an appropriate amount of disinfectant gel (2-3ml) on the palm, rub your hands together to make it evenly spread on each part (ensure that the liquid covers the entire surface), Follow the WS/T313 "Specification of hand hygiene for health care workers " Appendix A, the method of hand washing for medical workers, rub and disinfect for 1 minute. Surgical hand disinfection：1. Wash hands and forearms, rinse thoroughly and dry. 2. Take an appropriate amount of disinfectant gel (5-10ml), follow the WS/T313 "Specification of hand hygiene for health care workers " Appendix C Surgical no-wash disinfection method, rub your hands and forearms to the lower third of the upper arms for 3 minutes.Wear sterile gloves after drying.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer, triethanolamine, glycerol, purified 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.Application soope 1. Sanitary hand disinfeotion: suitable for hand disinfeotion of medical staff in out patient。linios, wards, emergency room. intensive care units，hemodialysis rooms, and endoscopy rooms of medical and health institutions. It is suitable for quick disinfeotion of hands of persons who need to perform hand hygiene. 2. Surgical hand disinfection: suitable for preoperative surgical hand disinfection in the operating room of medical and health inst itutions.
Purpose
Information about the drug product’s indications for use.Germicidal spectrum Antiseptic, Hand Sanitizer. It can kill the microorganisms such as enter ic pathogenic bacteria, pyogenic coccus, pathogenic yeast and hospital infect ion common germs.
Spl product data elements
Usually a list of ingredients in a drug product.Wash-Free Surgical Hand Disinfectant Gel II Ethanol ALCOHOL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE GLYCERIN WATER
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 package label is attached 81630-003-01
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.Disinfectant type Antiseptic, Hand Sanitizer
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.Cautions 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