Active Ingredients
Polyhexamethylene biguanidine(0.4%).
Disposable Disinfectant
FDA Label NDC 74762-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hunan Cihui Medical Technology Co., Ltd. for the product Disposable Disinfectant (NDC 74762-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial disinfectant
Uses
Warnings
Store in a cool, dry,well-ventilated and clean room with relative humidity not exceeding
80% and no corrosive gases.
Directions
1,Total skin disinfection:apply directly to skin,either by spraying or wiping, for 1 minute
2,Mucous membrane disinfection(not suitable for use on vaginal mucosa) ;
2.1,Rinse oral cavity using the undiluted solution for 1 minute.Rinse mouth out with water after disinfecting.
2.2,Apply directly to the membrane and rub into the surface for one minute.
3, Hand sanitizing：Apply directly to hands,either by spraying or wiping, and rub in for 1 minute.
4,Hand sanitizing for surgical purposes：Apply directly to hands, either by spraying, wiping, or soaking in the undiluted solution, for 3 minutes.
5,Disinfecting the surfaces of objects：Apply directly to the surface, either by spraying or wiping, for 10 minutes.
Other Information
1, If there is any precipitation observed as a result of the storage process, this is a normal phenomenon and does not affect the product's efficacy.
2, For external use only,oral administration is strictly prohibited.
3,Please keep the product out of reach of children.
4, When used for mucous membrane disinfection,this should be limited to diagnosis and treatment inside medical institutions.
5, Do not use if any allergies against polyhexamethylene biguanidene are known, people with allergies should use with caution.
6,This product cannot be used together with soap or other anionic detergents.
7, This product has a moderately corrosive effect on carbon steel, but is suitable for the disinfection of copper,
stainless steel,aluminum, and ceramic surfaces.
Inactive Ingredients
Water,citric acid,aromatics,alcohol.
Package Label - Principal Display Panel
5 (500)
1 (50)
2 (70)
3 (200)
4 (250)
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