Pedi-Derm Bum

Manufacturer: Elixir Solutions, Inc. | Fragrance Manufacturing, Inc.
Effective date: 2023-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:17:18

Label at a glance#

ProductPedi-Derm Bum

Active ingredientZINC OXIDE

Label structure8 sections

Indications and uses

Treats diaper rash and skin irritations

Dosage and administration

Apply a thick coat after diaper change, especially at bedtime. If baby cries during application it is because of their sensitive skin, this product does not sting. Use soft cloth or paper towel to clean bottom.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (CI 77947) 25%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

Treats diaper rash and skin irritations

Warnings

WARNINGS SECTION

For external use only. Do not use in the eyes or if you allergic to any of the ingredients. Stop use and ask a doctor if you need to use longer than 1 week or condition worsens.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Other Information:

OTHER SAFETY INFORMATION

Do not store in conditions of excess humidity or heat beyond 42°C (107°F).
Do not use if seal under cap is missing or broken.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Bismuth Subgallate, Gossypium Herbaceum (Cotton) Seed Oil, Lanolin, Zea Mays (Corn) Starch.

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Letourneau’s Pharmacy

Pedi-Derm Bum Paste™

Compounding Prescriptions Since 1926

Net WT
4oz (120g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69715-100-01	2025-01-30	C162847	48780-1	2cef2736-9703-d83d-e063-dadaa90ab31f	Letourneau’s Pharmacy Pedi-Derm Bum Paste

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69715-100	PEDI-DERM BUM (ZINC OXIDE) PASTE [ELIXIR SOLUTIONS, INC.]	3	Legacy NDC	20231223_867efd8d-1507-4543-afdf-d717102330f6.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Pedi-Derm Bum
Zinc Oxide
BISMUTH SUBGALLATE
LEVANT COTTONSEED OIL
LANOLIN
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69715-100	69715-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
BISMUTH SUBGALLATE	YIW503MI7V	IACT
LEVANT COTTONSEED OIL	N5CFT140R8	IACT
LANOLIN	7EV65EAW6H	IACT
STARCH, CORN	O8232NY3SJ	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4d76d59c-8cf4-43d0-e063-6394a90a59e2			867efd8d-1507-4543-afdf-d717102330f6	2026-03-20	Warnings	Exact identifier spl set id: 867efd8d-1507-4543-afdf-d717102330f6

Reported adverse events (FAERS/openFDA)#

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