H2OCEAN NOTHING

Manufacturer
H2Ocean, LLC
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:34:30

Label at a glance#

ProductH2OCEAN NOTHING
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• first aid to help reduce the risk of infection in: • minor cuts • scrapes • burns • first aid for the temporary relief of pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • rashes due to poison ivy

Dosage and administration

• clean the affected area • adults and children 2 years of age and older: 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: do not use, consult a physician

Storage and handling

• this package is child-resistant • store at room temperature

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Cl 0.13%
Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic
Pain reliever

Uses

INDICATIONS & USAGE SECTION

• first aid to help reduce the risk of infection in: • minor cuts • scrapes • burns
• first aid for the temporary relief of pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • rashes due to poison ivy

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 • in large quantities, particularly over raw surfaces or blistered areas

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

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• clean the affected area
• adults and children 2 years of age and older: 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: do not use, consult a physician

Other information

STORAGE AND HANDLING SECTION

• this package is child-resistant
• store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

+1-772-219-8183

SPL UNCLASSIFIED SECTION

First In First Aid

ACTS IN 2 MINUTES

LASTING UP TO 20 MINUTES

MAX STRENGTH

Antiseptic and Anesthetic

RECYCLABLE

Distributed By
H2Ocean, LLC.

Stuart, FL,
USA 34997

Distributed in Europe By
H2Ocean Europe SARL, LTD.
Waterford
Ireland, X91 EH5N

USA. / EU. +1-772-219-8183

info@h2ocean.com
www.h2ocean.com
Made in USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nothing-104Nothing-104

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70411-104-50H2OCEAN NOTHING50 mL in 1 BOTTLE, PUMPLIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70411-104H2OCEAN NOTHING (BENZALKONIUM CL, LIDOCAINE HCL) LIQUID [H2OCEAN, LLC]1Current NDC, 1 package rows20241107_77896ac3-960c-41ac-8b40-053f24526fe3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70411-10470411-104-50

Ingredients#

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

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

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
H2OCEAN NOTHINGBENZALKONIUM CL, LIDOCAINE HCLH2Ocean, LLC77896ac3-960c-41ac-8b40-053f24526fe32024-10-23WarningsExact identifier
ndc (package): 70411-104-50
ndc (product): 70411-104
ndc11 (package): 70411010450
spl id: 23f1ddb8-4c71-48a4-b8d2-32bf0d0dfe46
spl set id: 77896ac3-960c-41ac-8b40-053f24526fe3

Reported adverse events (FAERS/openFDA)#

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