Drug Facts
Active ingredient
Benzalkonium Chloride 0.13%
Betadine Foam Cleanser Aerosol, Foam
FDA Label NDC 67618-184
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Betadine Foam Cleanser (NDC 67618-184). 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 drug facts, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- antimicrobial skin cleanser to help reduce bacteria that can potentially cause disease
- helps to prevent the spread of bacteria
Warnings
For external use only
When Using This Product
do not use in or near eyes.
Stop Use And Ask A Doctor If
irritation and redness develop.
Keep Out Of Reach Of Children.
If swallowed, seek medical attention or contact a Poison Control Center immediately.
Directions
- wet area to be cleaned with clean, running water
- apply appropriate amount of product
- lather and scrub for at least 1 seconds
- rinse thoroughly with running water
- dry completely
Other Information
Store in a cool, dry place below 104° F (40° C)
Inactive Ingredients
Water, glycerin, cocamidopropyl betaine, lauramine oxide, ethylene glycol phenyl ether, fragrance, cocamide MEA, tetrasodium EDTA, PEG-150 distearate, aloe barbadensis leaf juice.
Questions?
1-833-288-2684
Package Labels
BETADINE®
HAND & SKIN
CLEANSER
Antimicrobial
Foam Skin Cleanser
Hospital Grade,
Broad Spectrum
Germ Killing*
Great for Hand
& Skin Hygiene
Skin Softening
Formula
with Aloe
HAND WASHING
GENERAL SKIN CLEANSING
8 fl oz (237 mL)
Front Label (Frontlabel)
BETADINE®
HAND & SKIN CLEANSER
*Based on in vitro lab testing
Dist. by: Atlantis Consumer Healthcare Inc., Bridgewater, NJ 08807 USA
Betadine is a registered trademark of Atlantis Consumer Healthcare Inc
© 2025 Atlantis Healthcare Inc. A0925
Back Label (Backlabel)
BETADINE®
HAND & SKIN
CLEANSER
Antimicrobial Foam
Skin Cleanser
NEW!
Hospital Grade,
Broad Spectrum
Germ Killing*
Kills 99.9% of 20
Different Bacteria
in Seconds*
Great for Hand
& Skin Hygiene
Skin Softening
Formula
with Aloe
HAND WASHING
GENERAL SKIN CLEANSING
8 fl oz (237 mL)
Distributed by:
Atlantis Consumer Healthcare Inc., Bridgewater, NJ 08807 USA
Betadine is a registered trademark of Atlantis Consumer
Healthcare Inc.
© 2025 Atlantis Health Care Inc.
*Based on in vitro lab testing
A0925
Carton Label (Carton)
* Please review the disclaimer below.
