Otc - Active Ingredient
Benzalkonium Chloride 0.125%
Assured
FDA Label NDC 52629-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Higiene + Salud, S.a. De C.v. for the product Assured (NDC 52629-800). 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, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, 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.
Label Section Quick Index
Otc - Purpose
Antibacterial
Otc - Do Not Use
Over large areas of the body if you are allergic to any of the ingredients.
Otc - When Using
Do not get into eyes.
If contact occurs, rinse thoroughly with water.
Otc - Stop Use
If irritation or rash develops and continues for more than 72 hours.
Otc - Ask Doctor
If irritation or rash develops and continues for more than 72 hours.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
· Thoroughly wipe hands and face as desired.
· allow to dry without wiping.
· Discard wipe in trash receptacle after use. Do not flush.
Storage And Handling
Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.
Dosage & Administration
Dosage: Swab - Administration: Topical
Summary Of Safety And Effectiveness
- Convenient
- Clean-up
- Moisturize
Easy to use & carry anywhere!
Use to wash up quickly when soap and water are not available.
Contains soothing Aloe to help moisturize your skin and leave it feeling soft and smooth.
Package Label.Principal Display Panel
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