FDA.reportPublic FDA data

Nothing

Manufacturer
H2Ocean, LLC | Products by O2, Inc.
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:27

Label at a glance#

ProductNothing
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of pain and/or itching associated with minor skin irritations

Dosage and administration

Adults and children 2 years of age and older:   Apply 1-2 pumps of the foam soap to the affected area 3-4 times daily. Children under 2 years of age: consult a doctor. For best results, do not use with alcohol based products.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocane hydrochloride, 4%

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and/or itching associated with minor skin irritations

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.  In case of eye contact, flush eyes with water.

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly on raw surfaces of blistered areas.

OTC - STOP USE SECTION

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

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

Adults and children 2 years of age and older:  Apply 1-2 pumps of the foam soap to the affected area 3-4 times daily.

Children under 2 years of age: consult a doctor.

For best results, do not use with alcohol based products.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Poloxamer, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Disodium ETDA, Sea Salt

SPL UNCLASSIFIED SECTION

Questions? 1-888-420-2326

SPL UNCLASSIFIED SECTION

H2Ocean (r)

First In First Aid (TM)

H2Ocean's Nothing is the choice for first aid when ou want to feel NOTHING.

H2Ocean, LLC, Stuart, FL, USA

H2Ocean Europe SRL LTD., Waterford, Ireland

USA / EU +1 772.219.8183

Info@H2Ocean.com

Made in USA

www.H2Ocean.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H2Ocean(r)

First In First Aid (TM)

NOTHING (TM)

Pain Relieving Soap with Lidocaine

Anesthetic

1.7 Fl. Oz. (50 ml.)

20180130 102 H2Ocean Nothing20180130 102 H2Ocean Nothing

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70411-102-502025-01-30C16284748780-1ba0f9c33-55dc-a910-e053-dadaa90a0b85ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d
70411-102-502021-12-10C16284748780-1ba0f9c33-55dc-a910-e053-dadaa90a0b85ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d
70411-102-502021-01-29C16284748780-1ba0f9c33-55dc-a910-e053-dadaa90a0b85ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70411-102-50Nothing50 mL in 1 BOTTLELIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70411-102NOTHING (LIDOCAINE) LIQUID [H2OCEAN, LLC]3Legacy NDC, 1 package rows20231031_ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d.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
70411-10270411-102-50

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
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
POLOXAMER 1241S66E28KXAIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DISODIUM ETHYLENEDIAMINEDIACETATEEQL53S5L0FIACT
SODIUM CHLORIDE451W47IQ8XIACT

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
ec7d90f8-f52d-40ac-95f0-1e40b1df56ebce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d2023-10-30WarningsExact identifier
spl id: ec7d90f8-f52d-40ac-95f0-1e40b1df56eb
spl set id: ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d

Reported adverse events (FAERS/openFDA)#

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