FDA.reportPublic FDA data

Boogie Bottoms

Manufacturer
Nehemiah Manufacturing Company LLC | Trividia Manufacturing Solutions, Inc.
Effective date
2019-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:22

Label at a glance#

ProductBoogie Bottoms
Active ingredientDimethicone, Zinc 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 diapers promptly. Cleanse diaper area and allow to dry. Shake bottle well before use. Unlock to spray. Re-lock when not in use. Spray 4-6 inches from skin. No rub-in is required. Apply liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Storage and handling

Store at 59° F - 87° F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Zinc Oxide 25%Skin Protectant
Dimethicone 20%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.

OTC - WHEN USING SECTION

  • When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

  • Stop use and ask doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • Lock when not in use.
  • If swallowed, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly.
  • Cleanse diaper area and allow to dry.
  • Shake bottle well before use. Unlock to spray.
  • Re-lock when not in use.
  • Spray 4-6 inches from skin. No rub-in is required.
  • Apply liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information

STORAGE AND HANDLING SECTION

Store at 59° F - 87° F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum

Questions?

OTC - QUESTIONS SECTION

1.877.469.8877 - MADE IN USA

SPL UNCLASSIFIED SECTION

Distributed by Nehemiah Manufacturing Co,
1907 South St, Cincinnati, OH U.S.A. 45204

PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!
NDC 75957-003-01

Boogie
BOTTOMS™

No-Rub
Diaper Rash Spray
Skin Protectant

SHAKE
WELL

Treats & Prevents diaper rash

Spray-on application

Fast & Easy to use

25% Zinc Oxide

Free from:
fragrances • dyes • parabens

NET 1.7 FL OZ (49ML)

PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75957-003-012023-01-30C16284748780-1f386c649-a9e5-0266-e053-dadaa90a7c1aBoogie Bottoms™
75957-003-022023-01-30C16284748780-1f386c649-a9e5-0266-e053-dadaa90a7c1aBoogie Bottoms™
75957-003-032023-01-30C16284748780-1f386c649-a9e5-0266-e053-dadaa90a7c1aBoogie Bottoms™
75957-003-042023-01-30C16284748780-1f386c649-a9e5-0266-e053-dadaa90a7c1aBoogie Bottoms™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75957-003-01Boogie Bottoms49 mL in 1 BOTTLESPRAY492
75957-003-02Boogie Bottoms3 in 1 CELLO PACKSPRAY32
75957-003-03Boogie Bottoms4 in 1 CELLO PACKSPRAY42
75957-003-04Boogie Bottoms1 in 1 BOXSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75957-003BOOGIE BOTTOMS (DIMETHICONE AND ZINC OXIDE) SPRAY [NEHEMIAH MANUFACTURING COMPANY LLC]2Legacy NDC, 4 package rows20200122_adbbc8cb-aacc-4360-922d-56d97bb1f805.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75957-00375957-003-01, 75957-003-02, 75957-003-03, 75957-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Zinc OxideSOI2LOH54ZACTIB
CYCLOMETHICONENMQ347994ZIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PETROLATUM4T6H12BN9UIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CHOLECALCIFEROL1C6V77QF41IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
CORN OIL8470G57WFMIACT

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
c07c6cfb-d6dc-44fb-8226-2beab465103cadbbc8cb-aacc-4360-922d-56d97bb1f8052019-03-19WarningsExact identifier
spl id: c07c6cfb-d6dc-44fb-8226-2beab465103c
spl set id: adbbc8cb-aacc-4360-922d-56d97bb1f805

Reported adverse events (FAERS/openFDA)#

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