Otc - Active Ingredient
Active ingredient
Benzalkonium chloride 0.13%
Complete Soap
FDA Label NDC 63900-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simoniz Saniclean, Llc for the product Complete (NDC 63900-101). 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
Purpose
Antimicrobial
Indications & Usage
Uses
For handwashing to decrease bacteria on skin.
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
On infants under 6 months of age.
Otc - When Using
When using this product
- Avoid contact with eyes.
- In case of eye contact, flush with water for 15 minutes.
Otc - Stop Use
Stop use and ask a doctor if
Irritation or redness develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, drink a large quantity of water and seek medical help or contact a poison control center.
Dosage & Administration
Directions
Apply a small amount to wet hands, and rub lightly together to produce a rich lather. Rinse hands thoroughly with water, and dry skin with a clean towel.
Other Information
- Store at room temperature.
- Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Inactive Ingredient
Inactive ingredients
water; PEG-7 glyceryl cocoate; lauramine oxide; glycerin; fragrance (linalool, (+/-)-; .alpha.-amylcinnamaldehyde; butylphenyl methylpropional; geraniol; coumarin; benzyl salicylate); anhydrous citric acid; edetate disodium; FD&C yellow no. 5; D&C red no. 33
Other
LOT
EXP:
Simoniz Saniclean, LLC
299 Dividend Road
Rocky Hill, CT 06067
1-800-227-5536
Package Label.Principal Display Panel
SaniClean
SIMONIZ
HAND CARE
Complete
Lotion Hand Soap
with
Benzalkonium Chloride
NET CONTENTS: 1 U.S. gallon (378 l)
* Please review the disclaimer below.
