MEDPAK DERMA GUARD- zinc oxide ointment
Elba, Inc.

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.

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MedPak Derma Guard Ointment

Drug Facts

Active Ingredient

Zinc Oxide 9.6%

Purpose

Skin Protectant

Use:

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

Warning:

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 promtly. 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:

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

Package Labeling:

Label2

MEDPAK DERMA GUARD
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10031-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	96 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10031-011-00	113 g in 1 TUBE; Type 0: Not a Combination Product	08/11/2017	08/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/11/2017	08/11/2017

Labeler - Elba, Inc. (108428483)

Revised: 1/2021

Document Id: 9996ec2d-28dc-7d91-e053-2a95a90a89f0

Set id: 8602db7e-5058-408b-aa01-31958608199f

Version: 2

Effective Time: 20210126

Elba, Inc.