FDA.reportPublic FDA data

O2hundred

Manufacturer
Tov Innovation Co.Ltd
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:44:20

Label at a glance#

ProductO2hundred
Active ingredientOXYGEN
Label structure11 sections

Indications and uses

Increased blood oxygen saturation.

Dosage and administration

Follow the picture in the manual for how to use this product. 1. Open the plastic bottle cap and remove the dedicated injector. 2. Put an oxygen cartridge in the injector. 3. Turn the water bottle upside down and return the handle. 4. When oxygen is injected, shake it for about 10 seconds before drinking.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Oxygen 99.9%

Purposes

OTC - PURPOSE SECTION

Maintain good oxygen levels

Uses

INDICATIONS & USAGE SECTION

Increased blood oxygen saturation.

Warnings

OTC - DO NOT USE SECTION

Keep away from fire.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if Irritation or rash appears and lasts

Warnings

OTC - WHEN USING SECTION

When using this product

Do not eat more than twice a day.

Use only for PET bottles of specified size.

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Follow the picture in the manual for how to use this product.
1. Open the plastic bottle cap and remove the dedicated injector.
2. Put an oxygen cartridge in the injector.
3. Turn the water bottle upside down and return the handle.
4. When oxygen is injected, shake it for about 10 seconds before drinking.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ASCORBIC ACID

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

o2o2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83508-301-012024-12-25C16284748780-11030e364-fffc-111a-e063-dadaa90a10e283508-301 O2hundred
83508-301-012024-07-30C16284748780-11030e364-fffc-111a-e063-dadaa90a10e283508-301 O2hundred
83508-301-012024-01-30C16284748780-11030e364-fffc-111a-e063-dadaa90a10e283508-301 O2hundred

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83508-30183508-301-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYGENS88TT14065ACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT

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
2a11bae5-9f0a-220d-e063-6394a90af1fbfd5c14f2-ec49-1eb2-e053-6394a90a83272024-12-24WarningsExact identifier
spl id: 2a11bae5-9f0a-220d-e063-6394a90af1fb
spl set id: fd5c14f2-ec49-1eb2-e053-6394a90a8327

Reported adverse events (FAERS/openFDA)#

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