PEDI-DERM BUM- zinc oxide paste

Pedi-Derm Bum by

Drug Labeling and Warnings

Pedi-Derm Bum by is a Otc medication manufactured, distributed, or labeled by Elixir Solutions, Inc., Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide (CI 77947) 25%

Purpose

Skin Protectant

Uses:

Treats diaper rash and skin irritations

Warnings

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.

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

Directions:

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.

Other 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:

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

Principal Display Panel - Carton Label

Letourneau’s Pharmacy

Pedi-Derm Bum Paste™

Compounding Prescriptions Since 1926

Net WT
4oz (120g)

INGREDIENTS AND APPEARANCE

PEDI-DERM BUM 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69715-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BISMUTH SUBGALLATE (UNII: YIW503MI7V)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
LANOLIN (UNII: 7EV65EAW6H)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69715-100-01	120 g in 1 JAR; Type 0: Not a Combination Product	10/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/05/2015

Labeler - Elixir Solutions, Inc. (070917614)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(69715-100)