FDA.reportPublic FDA data

Boudreauxs

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:46:17

Label at a glance#

ProductBoudreauxs
Active ingredientZINC OXIDE
Label structure12 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 diaper immediately.   Cleanse the diaper area and allow to dry. Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide, 40%

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

Warning

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after 7 days.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

to prevent accidental ingestion.

If swallowed, seek medical help or call Poison Control Center immediately.

Directions for Use

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diaper immediately.  
  • Cleanse the diaper area and allow to dry.
  • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime.

Other Information

OTHER SAFETY INFORMATION

  • Store at room tempature, 20C to 27C (68F to 80F)
  • Remove seal from jar before use.
  • Use with infants, children and adults.
  • Will stain clothing and fabric.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
BOUDREAUX’S
BUTT PASTE
NET WT. 14 OZ (397 g)

MAXIMUM STRENGTH BOUDREAUX’S BUTT PASTE NET WT. 14 OZ (397 g)MAXIMUM STRENGTH BOUDREAUX’S BUTT PASTE NET WT. 14 OZ (397 g)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0194BOUDREAUXS (ZINC OXIDE) PASTE [C.B. FLEET COMPANY, INC.]4Legacy NDC20241215_584ccf7d-c355-45eb-bb4f-fd2f154fbd89.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
0132-01940132-0194-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
CASTOR OILD5340Y2I9GIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
BALSAM PERU8P5F881OCYIACT
PETROLATUM4T6H12BN9UIACT

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
baae5b4e-dcf7-49e0-b4d2-318d645f919b584ccf7d-c355-45eb-bb4f-fd2f154fbd892025-11-19WarningsExact identifier
spl set id: 584ccf7d-c355-45eb-bb4f-fd2f154fbd89

Reported adverse events (FAERS/openFDA)#

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