Otc - Purpose
Antibacterial
Cloralen Tm Antibacterial Wipes
FDA Label NDC 70697-802
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 Cloralen Tm Antibacterial Wipes (NDC 70697-802). 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 - purpose, otc - active ingredient, indications & usage, warnings, 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 - Active Ingredient
BENZALKONIUM, CHLORIDE 0.125%
Indications & Usage
Hand sanitizer to help reduce bacteria on the skin
Warnings
For external use only.
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 throughly 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
Instructions For Use
- wet hands throughly with product and allow to dry.
-discard wipe in trash receptacle after use. Do not flush
- chuldren under 6 years af age should be supervised whe using this product
Inactive Ingredient
water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol
Dosage & Administration
Topical admistration
* Please review the disclaimer below.
