Kolmed Hand Sanitizing Wipes
FDA Label NDC 75670-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Sanjun General Merchandise Co., Ltd. for the product Kolmed Hand Sanitizing Wipes (NDC 75670-008). 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 0.2%
Purpose
Antiseptic
Uses
• hand wipes to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available
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. Do not inhale
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 thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing
• discard wipe in trash after use. Do not flush
Other Information
• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredient
Inactive ingredients aloe vera (Aloe barbadensis) leaf juice, citric acid, decyl glucoside, ethylhexylglycerin,
fragrance, glycerin, phenoxyethanol, polysorbate 20, potassium sorbate, sodium benzoate,tocopheryl acetate, water
Packaging
Image Description (79517001 4)
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