FDA.reportPublic FDA data

BABYSONS

Manufacturer
Laboratorios Quimica Son's, S.A. de C.V
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:32:51

Label at a glance#

ProductBABYSONS
Active ingredientDEXPANTHENOL
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dexpanthenol 5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area and allow to dry
  • Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

SPL UNCLASSIFIED SECTION

Keep the tube tightly closed and store at no higher temperature than 86°F / 30°C.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lanolin, beeswax, cetyl alcohol, polysorbate 60, polysorbate 80, stearyl alcohol, water, white petrolatum, zinc oxide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249792dexpanthenol 5 % Topical OintmentPSN4
249792dexpanthenol 0.05 MG/MG Topical OintmentSCD4
249792dexpanthenol 5 % Topical OintmentSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73519-001-302023-02-03C16284748780-1f386c649-efb2-0266-e053-dadaa90a7c1aBABYSONS
73519-001-302023-01-30C16284748780-1f386c649-efb2-0266-e053-dadaa90a7c1aBABYSONS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73519-001-30BABYSONS30 g in 1 TUBEOINTMENT304
73519-001-30BABYSONS1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73519-001BABYSONS (DEXPANTHENOL) OINTMENT [LABORATORIOS QUIMICA SON'S, S.A. DE C.V]4Current NDC, Legacy NDC, 2 package rows20241102_8a4782fc-5917-4f63-b9bf-6597be2afc6c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73519-00173519-001-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ALCOHOL936JST6JCNIACT
POLYSORBATE 60CAL22UVI4MIACT
POLYSORBATE 806OZP39ZG8HIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZIACT
DEXPANTHENOL1O6C93RI7ZACTIB

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
BABYSONSDEXPANTHENOLLaboratorios Quimica Son's, S.A. de C.V8a4782fc-5917-4f63-b9bf-6597be2afc6c2024-10-31WarningsExact identifier
ndc (package): 73519-001-30
ndc (product): 73519-001
ndc11 (package): 73519000130
spl id: 25cb134c-b31f-af58-e063-6394a90adbb7
spl set id: 8a4782fc-5917-4f63-b9bf-6597be2afc6c

Reported adverse events (FAERS/openFDA)#

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