FDA.reportPublic FDA data

Boudreauxs

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:39:52

Label at a glance#

ProductBoudreauxs
Active ingredientZINC OXIDE
Label structure10 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 prolonged period of time, such as bedtime

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide, 16%

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

avoid contact with the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens or does not improve after 7 days

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) 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 prolonged period of time, such as bedtime

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature, 15C-25C (59F-77F )
  • Remove foil seal from the tube's tip

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, beeswax, citric acid, copernicia cerifera (carnauba) wax, hydrogenated castor oil, myroxylon pereirae (balsam peru) oil, ricinus communis (castor) seed oil  

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TREATS & PROTECTS

BOUDREAUX’S
BUTT PASTE

DIAPER RASH OINTMENT
SKIN PROTECTANT/ ZINC OXIDE 16%

WITH NATURAL* ALOE

NET WT.
4OZ (113 g)

TREATS & PROTECTS BOUDREAUX’S BUTT PASTE DIAPER RASH OINTMENT SKIN PROTECTANT/ ZINC OXIDE 16% WITH NATURAL* ALOE NET WT. 4OZ (113 g)TREATS & PROTECTS BOUDREAUX’S BUTT PASTE DIAPER RASH OINTMENT SKIN PROTECTANT/ ZINC OXIDE 16% WITH NATURAL* ALOE NET WT. 4OZ (113 g)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0334-44Boudreauxs113 g in 1 TUBECREAM1137

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z3
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z3
ALOEINACTIVE INGREDIENTV5VD430YW93
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
BALSAM PERUINACTIVE INGREDIENT8P5F881OCY3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ3
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F3

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
0132-03340132-0334-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
BEESWAX2ZA36H0S2VIACT
CITRIC ACID2968PHW8QPIACT
CARNAUBA WAXR12CBM0EIZIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
BALSAM PERU8P5F881OCYIACT
CASTOR OILD5340Y2I9GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-07-01full-release2026-06-01 00:14:39

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
4 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
6 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
4 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
6 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
4 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
6 equally ranked IID candidates

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
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
ndc (package): 0132-0334-44
ndc (product): 0132-0334
ndc11 (package): 00132033444
spl id: a0a6ee4a-fae8-4795-ab6f-c2470e9ed7c1
spl set id: 262278f6-7e4c-44ee-b40d-39662a239d73

Reported adverse events (FAERS/openFDA)#

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