Otc - Active Ingredient
Benzalkonium Chloride....0.125%
Aquarelle
FDA Label NDC 70697-805
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 Aquarelle (NDC 70697-805). 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 and precautions, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antibaterial
Indications & Usage
For hand washing to decrease bacteria on the skin. May be used on face, arms and legs
Throughly wipe hands and face as desired.
Allow to dry without wiping.
Discard wipe in trash receptacle after use. Do not flush
Warnings And Precautions
for external use only
Otc - Do Not Use
If you are allergic to any of the ingredients
Otc - When Using
Di 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
Storage And Handling
Store at room temperature. Cold weather may cloud this product. It´s antisceptic properties are not affected
Inactive Ingredient
Demineralised water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Methylchloroisothiazolinone / Methylisothiazolinone, Fragrance, Aloe Vera Extract, Tretasodium EDTA, Citric Acid, D-alpha Tocopheryl Acetate.
Dosage & Administration
Dossage: swab
Administration: Topical
Instructions For Use
To dispense wipe: Peel back front label slowly. Remove wipes
To resela Pouch: Firmly run thumb over the label
Warnings
For external use only
* Please review the disclaimer below.
