Otc - Active Ingredient
Polyhexamethylene biguanide 0.09% (w/w)
The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Meilei Electrical Appliance Co.,ltd for the product Alcohol Free Antibacterial Hand Sanitizer (NDC 82658-002). 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 otc - active ingredient, inactive ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Polyhexamethylene biguanide 0.09% (w/w)
Medical Glycerin,Benzalkonium Chloride,Purified water
Health care personnel hand rub to help reduce bacteria that potentially can cause disease.
For external use only.Use with caution in people with polxhexammethyl metformin and quaternary ammonium allergies.
Do notuse in children less than 2 months of age
Do notuse on open skin wounds
Avoid compatibility with soap and anions, and do not share it with other detergents
When using this product keep out of eyes, ears,and mouth. In case of contact with eyes, rinse eyesthoroughly 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 rightaway.
Antiseptic
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.
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.
Store between 5-40℃(41-104℉)
Avoid freezing and excessive heat above 50℃(122℉)
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