FDA.reportPublic FDA data

BabyO2

Manufacturer
Oxigenesis, Inc.
Effective date
2020-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:13

Label at a glance#

ProductBabyO2
Active ingredientSILVER, ZINC, HYPOCHLOROUS ACID
Label structure7 sections

Indications and uses

Relieves and prevents the discomfort and symptoms from: diaper rash, chaffed skin, minor burns and abrasions.

Dosage and administration

Change wet and solid diapers promptly. Cleanse diaper area and dry. Apply serum liberally as often necessary with every diaper change, especially at bedtime. Other information Store at 20°-25°C (68° -70° F)

Label contents#

Full prescribing information#

Active Ingredient                                                           Purpose

OTC - ACTIVE INGREDIENT SECTION

Colloidal Silver 48 mg ................................................   Skin Protectant
Colloidal Zinc   6 mg .................................................... Skin Protectant
HOCl 66 mg ...............................................................  Antimicrobial   

Uses

INDICATIONS & USAGE SECTION

Relieves and prevents the discomfort and symptoms from: diaper rash, chaffed skin, minor burns and abrasions.

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not use over puncture wounds, infections or lacerations. Avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve in 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Change wet and solid diapers promptly. Cleanse diaper area and dry. Apply serum liberally as often necessary with every diaper change, especially at bedtime.

Other information
Store at 20°-25°C (68° -70° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Distilled water, Smectic Clay, Silicon Dioxide, HCl (buffering)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72136-007-012022-01-28C16284748780-1d6a99b39-fc80-a426-e053-dadaa90af4c229ec6096-918f-4b80-b601-6d8448f03a7f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72136-007-01BabyO2240 mL in 1 TUBELIQUID2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72136-007BABYO2 (SILVER, ZINC) LIQUID [OXIGENESIS, INC.]1Legacy NDC, 1 package rows20200926_29ec6096-918f-4b80-b601-6d8448f03a7f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72136-00772136-007-01

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
SILVER3M4G523W1GACTIB
ZINCJ41CSQ7QDSACTIB
HYPOCHLOROUS ACID712K4CDC10ACTIB
WATER059QF0KO0RIACT
LAPONITED703131383IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROCHLORIC ACIDQTT17582CBIACT

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
fdea110b-2734-4b2a-84f9-3bcdb469262329ec6096-918f-4b80-b601-6d8448f03a7f2020-09-17WarningsExact identifier
spl id: fdea110b-2734-4b2a-84f9-3bcdb4692623
spl set id: 29ec6096-918f-4b80-b601-6d8448f03a7f

Reported adverse events (FAERS/openFDA)#

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