FDA.reportPublic FDA data

Boudreauxs

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2025-10-30
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:41:22

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#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

WARNINGS SECTION

  • For external use only
  • When using this product 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 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 

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 temperature,  15C to  25 C ( 59F to  77F)
  • Remove foil seal from the tube's tip
  • Use with infants, children and adults 
  • Will stain clothing and fabric

Inactive Ingredients

INACTIVE INGREDIENT SECTION

 myroxylon pereirae (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil  

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TREATS & PROTECTS
BOUDREAUX’S
BUTT PASTE
MAX STRENGTH
NET WT. 2 OZ (57 g)

TREATS & PROTECTS BOUDREAUX’S BUTT PASTE MAX STRENGTH NET WT. 2 OZ (57 g)TREATS & PROTECTS BOUDREAUX’S BUTT PASTE MAX STRENGTH NET WT. 2 OZ (57 g)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOUDREAUX’S
BUTT PASTE
Zinc oxide 40%
MAX STRENGTH
NET WT. 4 OZ (113 g)

BOUDREAUX’S BUTT PASTE Zinc oxide 40% MAX STRENGTH NET WT. 4 OZ (113 g)BOUDREAUX’S BUTT PASTE Zinc oxide 40% MAX STRENGTH NET WT. 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOUDREAUX’S
BUTT PASTE
Zinc oxide 40%
MAX STRENGTH
NET WT. 14 OZ (396 g)

BOUDREAUX’S BUTT PASTE Zinc oxide 40% MAX STRENGTH NET WT. 14 OZ (396 g)BOUDREAUX’S BUTT PASTE Zinc oxide 40% MAX STRENGTH NET WT. 14 OZ (396 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0323-14Boudreauxs397 g in 1 JARCREAM39713
0132-0323-22Boudreauxs57 g in 1 TUBECREAM5713
0132-0323-44Boudreauxs113 g in 1 TUBECREAM11313

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z5
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z5
BALSAM PERUINACTIVE INGREDIENT8P5F881OCY5
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP5
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U5

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-03230132-0323-44, 0132-0323-22, 0132-0323-14

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 OXIDESOI2LOH54ZACTIB
BALSAM PERU8P5F881OCYIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
CASTOR OILD5340Y2I9GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-12-18full-release2026-06-01 00:43:13

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
4 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.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
ndc (package): 0132-0323-14
ndc (package): 0132-0323-22
ndc (package): 0132-0323-44
ndc (product): 0132-0323
ndc11 (package): 00132032344
ndc11 (package): 00132032322
ndc11 (package): 00132032314
spl id: a378c7d3-f792-4c05-b35b-03c8fbb1a5b4
spl set id: 59d90652-a471-4f77-a3d5-88aad9dc9e13

Reported adverse events (FAERS/openFDA)#

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