DIAPREX- zinc oxide cream

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

Zinc Oxide 9.6%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash.
• Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

• For External Use Only

When using this product

do not get into eyes.

Stop use and ask doctor

if condition worsens or symptoms last more than 7 days or clear up and occur again in a few days.

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 betime or anytime when exposure to wet diapers may be prolonged.

Other Information

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

Inactive Ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

DIAPREX 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10031-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	96 mg  in 1 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: 10031-006-04	70 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2017
2	NDC: 10031-006-05	18 in 1 BOX	02/15/2017
2		15 g in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/15/2017

Labeler - Elba, Inc. (108428483)