Otc - Active Ingredient
Benzalkonium chloride 0.1%
Sanitizing Wipes
FDA Label NDC 80144-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Condor Co., Ltd. for the product Sanitizing Wipes (NDC 80144-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic, Hand Sanitizer
Antiseptic, Hand Sanitizer
Indications & Usage
Hand sanitizer to help reduce bacteria on the skin.
For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Otc - Do Not Use
in children less than 2 months of age
on open skin wounds
Otc - When Using
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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
Dosage & Administration
Open packet, remove and unfold pre-moistened tissue. Wipe hands or affected area thoroughly, then discard properly after use. Reseal back after use to keep wipes fresh.
Storage And Handling
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Phenoxy Ethanol, Polyhexamethylene Biguanide Hydrochloride, Purified Water, Propylene Glycol, Ethyl Alcohol, Vitamin E, Lemon Terpenes, Aloe Vera Extract.
Package Label.Principal Display Panel
10 wipes NDC: 80144-001-01
35 wipes NDC: 80144-001-02
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