Flanders Buttocks

Manufacturer
Flanders Inc
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
monthly-update
Hydrated at
2026-06-03 17:52:11

Label at a glance#

ProductFlanders Buttocks
Active ingredientPETROLATUM, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness

Dosage and administration

change wet and soiled diapers promptly, cleanse the diaper area, allow to dry apply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 66.2%....................Skin Protectant

Zinc Oxide 13.4%..............................Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

Directions

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly, cleanse the diaper area, allow to dry
  • apply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

For External Use only

Do not Useover deep puncture wounds, infections, or lacerations.

When using this product avoid contact with eyes.

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Inactive Ingredients

INACTIVE INGREDIENT SECTION

castor oil, light mineral oil, peruvian balsam, white beeswax

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Other Information

INFORMATION FOR PATIENTS SECTION

  • store at room temperature
  • Lot No. and Exp Date: see crimp of tube
  • may stain clothing

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-855-NIX-RASH (1-855-649-7472)

Tube image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Image 1Tube Image 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086022Flanders Buttocks Ointment 13.4 % Topical OintmentPSN11
702006zinc oxide 13.4 % Topical OintmentPSN11
1086022zinc oxide 0.134 MG/MG Topical Ointment [Flanders]SBD11
702006zinc oxide 0.134 MG/MG Topical OintmentSCD11
1086022Flanders 0.134 MG/MG Topical OintmentSY11
1086022Flanders Buttocks Ointment 13.4 % Topical OintmentSY11
702006zinc oxide 13.4 % Topical OintmentSY11
702006ZNO 0.134 MG/MG Topical OintmentSY11
1086022ZNO 0.134 MG/MG Topical Ointment [Flanders]SY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130081642193442GTIN-13: 0081642193442
EAN-13: 0081642193442
GTIN-12: 081642193442
UPC-A: 081642193442
GTIN storage (14 digits): 00081642193442
cream jpeg 2024.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54323-215-02Flanders Buttocks113 g in 1 TUBEOINTMENT11311
54323-215-03Flanders Buttocks5 g in 1 PACKETOINTMENT511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54323-215-02GM - Gram54323-2151bfac02f-2726-484e-950c-e67d3b6d31ef12016-05-16

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
54323-21554323-215-02, 54323-215-03

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-10-14full-release2026-06-01 00:25:15

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
Flanders ButtocksWHITE PETROLATUM, ZINC OXIDEFlanders Inc32371159-c76d-41b0-e054-00144ff88e882026-01-09WarningsExact identifier
ndc (package): 54323-215-02
ndc (package): 54323-215-03
ndc (product): 54323-215
ndc11 (package): 54323021502
ndc11 (package): 54323021503
spl id: 47fab0f7-e37e-74d5-e063-6294a90a927f
spl set id: 32371159-c76d-41b0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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