Betadine®

Betadine®
SPL v1
SPL
SPL Set ID 3be9fa6e-3ae8-496b-876b-f81f1cd98af4
Route
TOPICAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Glycerin Cocamidopropyl Betaine Lauramine Oxide Phenoxyethanol Coco Monoethanolamide Edetate Sodium Peg-150 Distearate Aloe Vera Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-01

Description

Active ingredient Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Active ingredient Benzalkonium Chloride 0.13%

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

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
Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

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)

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

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

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.

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.


Structured Label Content

Uses
  • antimicrobial skin cleanser to help reduce bacteria that can potentially cause disease
  • helps to prevent the spread of bacteria
Purpose

Antiseptic

Warnings

For external use only

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
Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

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)

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

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

Other Information (Other information)

Store in a cool, dry place below 104° F (40° C)

Inactive Ingredients (Inactive ingredients)

Water, glycerin, cocamidopropyl betaine, lauramine oxide, ethylene glycol phenyl ether, fragrance, cocamide MEA, tetrasodium EDTA, PEG-150 distearate, aloe barbadensis leaf juice.

When Using This Product (When using this product)

do not use in or near eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness develop.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek medical attention or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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