FDA.reportPublic FDA data

Blue Green Foam

Manufacturer
H2Ocean, LLC
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:32:51

Label at a glance#

ProductBlue Green Foam
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

first aid to help prevent infection in minor • cuts • scrapes • burns

Dosage and administration

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

Storage and handling

• protect from freezing • do not use if shrink safety seal is broken

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Cl 0.13%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor • cuts • scrapes • burns

Warnings

WARNINGS SECTION

For external use only

Do not use • in the eyes or apply over large areas of the body
                  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if the condition persists or gets worse

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

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 2 years of age and older:
  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a 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 • do not use if shrink safety seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Poloxamer 407, Aloe (Aloe barbadensis) Leaf Juice, Disodium EDTA, Sea Salt

Questions?

OTC - QUESTIONS SECTION

+1-772-219-8183

SPL UNCLASSIFIED SECTION

BLUE GREEN FOAM SOAP®

FIRST AID ANTISEPTIC

Moisturizer • Contains Aloe

ALCOHOL & DYE FREE

Distributed by:

H2Ocean, LLC
Stuart, FL,
USA 34997

Distributed in Europe by:
H2Ocean Europe SARL, LTD
Waterford,
Ireland X91 EH5N

Made in USA

info@h2ocean.com
www.h2ocean.com

Unscented No Dyes GUARANTEED

VEGAN PRODUCTS

RECYCLABLE

Project/BlueGreen

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST AID ANTISEPTIC SOAP 473mLFIRST AID ANTISEPTIC SOAP 473mL

FIRST AID ANTISEPTIC SOAP 50mLFIRST AID ANTISEPTIC SOAP 50mL

FIRST AID ANTISEPTIC SOAP 207mLFIRST AID ANTISEPTIC SOAP 207mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN6
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD6
1020365benzalkonium chloride 0.13 % Topical FoamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70411-100-072021-12-10C16284748780-1ba0f9c33-5588-a910-e053-dadaa90a0b85BLUE GREEN FOAM
70411-100-082021-12-10C16284748780-1ba0f9c33-5588-a910-e053-dadaa90a0b85BLUE GREEN FOAM
70411-100-502021-12-10C16284748780-1ba0f9c33-5588-a910-e053-dadaa90a0b85BLUE GREEN FOAM
70411-100-072021-01-29C16284748780-1ba0f9c33-5588-a910-e053-dadaa90a0b85BLUE GREEN FOAM
70411-100-082021-01-29C16284748780-1ba0f9c33-5588-a910-e053-dadaa90a0b85BLUE GREEN FOAM
70411-100-502021-01-29C16284748780-1ba0f9c33-5588-a910-e053-dadaa90a0b85BLUE GREEN FOAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70411-100-07Blue Green Foam207 mL in 1 BOTTLE, PUMPLIQUID2076
70411-100-08Blue Green Foam237 mL in 1 BOTTLE, PUMPLIQUID2376
70411-100-09Blue Green Foam473 mL in 1 BOTTLELIQUID4736
70411-100-50Blue Green Foam50 mL in 1 BOTTLE, PUMPLIQUID506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70411-100BLUE GREEN FOAM (BENZALKONIUM CHLORIDE) LIQUID [H2OCEAN, LLC]6Current NDC, Legacy NDC, 4 package rows20241102_8627bf8b-2cce-45de-b37f-8478462645fa.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70411-10070411-100-50, 70411-100-08, 70411-100-07, 70411-100-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
SEA SALT87GE52P74GIACT

Source Document#

Source XML

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
Blue Green FoamBENZALKONIUM CHLORIDEH2Ocean, LLC8627bf8b-2cce-45de-b37f-8478462645fa2024-10-23WarningsExact identifier
ndc (package): 70411-100-09
ndc (package): 70411-100-08
ndc (package): 70411-100-07
ndc (package): 70411-100-50
ndc (product): 70411-100
ndc11 (package): 70411010050
ndc11 (package): 70411010008
ndc11 (package): 70411010007
ndc11 (package): 70411010009
spl id: fe1acb32-d100-4a47-b75d-1036c0d433ff
spl set id: 8627bf8b-2cce-45de-b37f-8478462645fa

Reported adverse events (FAERS/openFDA)#

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