Otc - Active Ingredient
Benzalkonium Chloride 0.125%
Assured
FDA Label NDC 70697-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indelpa, S.a. De C.v. for the product Assured (NDC 70697-800). 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, use, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, 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
Antibacterial
Use
Decreases bacteria on skin.
Otc - Do Not Use
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 rigth away.
Indications & Usage
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Instructions For Use
To dispense wipe: Peel back front label slowly. Remove wipes.
To reseal pouch: Firmly run thumb over the label.
Storage And Handling
Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.
Inactive Ingredient
Water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Vitamin E, Methylchloroisothiazolinone, Aloe Extract, Tetrasodium EDTA.
Dosage & Administration
Dosage: Swab
Administration: Topical
Summary Of Safety And Effectiveness
Assured TM Antibacterial Wet Wipes kills germs and bacteria, cleans and freshens your skin and gently wipes away perspiration and odor.
With moisturizing formula containing Aloe Vera and Vitamin E, Assured TM Antibacterial Wet Wipes are soft and gentle, and helping to nourish your skin as you freshen up.
This travel pack is convenitent to take along for use anytime or anywhere.
ASSURED
Antibacterial
Wet Wipes
Hand & face moisturizing towelettes
For hands and face
Ideal for travling
Moisturizing
Thick and soft cloths
Fresh scent
Package Label.Principal Display Panel
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