MEDPAK(TM) DERMA GUARD- zinc oxide ointment

medpak(TM) Derma Guard by

Drug Labeling and Warnings

medpak(TM) Derma Guard by is a Otc medication manufactured, distributed, or labeled by Elba, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

Keep out of reach of children.

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.

Inactive Ingredients

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

Product Labeling

INGREDIENTS AND APPEARANCE

MEDPAK(TM) DERMA GUARD 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10031-001
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

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: 10031-001-15	18 in 1 BOX	10/26/2016
1		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	10/26/2016

Labeler - Elba, Inc. (108428483)