Unit - Soft Antiseptic Hand Wash
FDA Label NDC 80407-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunitor, Ooo for the product Unit - Soft Antiseptic Hand Wash (NDC 80407-101). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzalkonium chloride 1%
Purpose
Antiseptic
Uses
■ for handwashing to decrease bacteria on the skin
■ recommended for repeated use
Warnings
For external use only
Do not use
■ in children less than 2 months of age
■ on open skin wounds
When using this product ■ do not get into eyes.In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
■ irritation and redness develop
■ condition persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ wet hands and forearms. Apply 1.5 ml to hands and forearms and foam. Scrub thoroughly for 1 minute, rinse and dry with towel, paper towel or hot air
■ supervise children under 6 years of age when using this product to avoid swallowing
Other Information
■ store between 15-30°C (59-86°F)
■ avoid freezing and excessive heat above 40°C (104°F)
Packaging
Image Description (80407101 2)
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