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Diaprex by Elba, Inc.

Dosage form: cream
Ingredients: ZINC OXIDE 96mg in 1g
Labeler: Elba, Inc.
NDC Code: 10031-006

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Diaprex

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:

DIAPREX 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10031-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION96 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN 
MAGNESIUM STEARATE 
WHITE WAX 
CASTOR OIL 
BALSAM PERU 
Packaging
#Item CodePackage Description
1NDC:10031-006-0470 g in 1 TUBE
2NDC:10031-006-0518 CUP in 1 BOX
215 g in 1 CUP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/15/2017
Labeler - Elba, Inc. (108428483)

 
Elba, Inc.

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Medically reviewed on Dec 29, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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