FDA.reportPublic FDA data

MAXIMUM STRENGTH BETADINE CLEAR SPRAY

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-03 03:04:41

Label at a glance#

ProductMaximum Strength Betadine Clear
Active ingredientBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

First aid to help prevent infection and relieve pain or discomfort in minor • cuts • scrapes • burns

Dosage and administration

• adults and children 2 years of age and older: • clean the affected area • spray a small amount of this product on the area 1 to 3 times daily • may be covered with sterile bandage • if bandaged, let dry first • children under 2 years of age: • consult a doctor

Storage and handling

• protect from freezing

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzalkonium Cl 0.13%

Pramoxine HCl 1.0%

Purpose

OTC - PURPOSE SECTION

First aid Antiseptic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection and relieve pain or discomfort in minor

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition or symptoms get worse or last more than 1 week
  • Symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with sterile bandage
  • if bandaged, let dry first
  • children under 2 years of age:
  • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel


MAXIMUM STRENGTH

BETADINE® CLEAR

FIRST AID SPRAY

Pain Relieving

Antiseptic

Cleansing spray

  • Ideal for Minor Cuts, wounds, scrapes & Burns
  • Kills 99.9% of Germs* To prevent Infection
  • Maximum Strength Pain Relief
  • No Stinging or Burning

6 FL OZ (177 mL)

Dist. by: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

www.betadine.com

©2023 Atlantis Consumer Healthcare Inc.

*commonly associated with skin infections.

Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.

MAXIMUM STRENGTH BETADINE® CLEAR SPRAY 6 OZ 177 ML
MAXIMUM STRENGTH BETADINE® CLEAR SPRAY 6 OZ 177 ML

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-18367618-183-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-07-18full-release2026-06-01 01:07:48

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
ndc (package): 67618-183-06
ndc (product): 67618-183
ndc11 (package): 67618018306
spl id: 074e0e6b-8391-4541-b628-bd74a5e7c29c
spl set id: 31b94a76-1536-47c0-ab03-e487c2625c58

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.