DIAPREX- zinc oxide ointment

Diaprex by

Drug Labeling and Warnings

Diaprex by is a Otc medication manufactured, distributed, or labeled by Elba, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

White Petrolatum 67.6% .................................................
Zinc Oxide 9.6%..............................................................

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash and other minor skin irritations.
• Protects chafed skin and helps seal out wetness

Warnings

• For External Use Only

When using this product

do not get into eyes.

If irritation occurs or if there is no improvement within 7 days discontinue use and consult a doctor.

Keep out of reach of children.

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

Directions:

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.

Other Information

Store at room temperature (59–86°F) (15-30°C)

Inactive Ingredients

Lanolin, Magnesium Stearate, White Beeswax, Castor Oil, and Balsam Peru.

Package Labeling:

INGREDIENTS AND APPEARANCE

DIAPREX 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10031-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.6 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	67.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MAGNESIUM STEARATE (UNII: 70097M6I30)
WHITE WAX (UNII: 7G1J5DA97F)
CASTOR OIL (UNII: D5340Y2I9G)
BALSAM PERU (UNII: 8P5F881OCY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10031-015-04	113 g in 1 JAR; Type 0: Not a Combination Product	01/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/04/2018

Labeler - Elba, Inc. (108428483)