BUM EASE - zinc oxide liquid
Wake Innovation, LLC

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.

----------

Active Ingredient

Zinc Oxide 10%

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 avoid contact with eyes.

Stop use and contact a doctor if:

• Condition worsens
• Symptoms last more than seven days or clear up and occur again within a few days.

• Keep this and all drugs out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Directions

• Shake Well Before Use
• Hold bottle 2-3 inches from baby’s bottom while spraying
• Press down on the pump to spray
• Change wet and solid diapers promptly
• Cleanse the diaper area, and allow to dry
• Apply spray liberally as often as necessary, with each diaper change, especially at
bedtime or anytime when exposeure to wet diapers may be prolonged

Other Information

• Store at 15° to 25°C (59° to 77°F)

Inactive Ingredients

*Aqua, *Arachis Hypogaea Oil *C14-22 Alcohol, *C12-20 Alkyl, *Coco-Caprylate/Caprate, *Cocoglycerides,
*Glucoside, *Glycerin, Phenoxyethanol Ethylhexylglycerin, *Oleic Acid and *Silica

*Natural Ingredients

Questions?

Call toll free 1-800-831-0507

Distributed by: Wake Innovation, LLC
P.O. Box 98355 Raleigh, NC
27624-8355 USA

Package Label

Image of Box Label

Nolan’s Diaper Rash Spray
Bum Ease ™

ZINC OXIDE SKIN PROTECTANT DIAPER RASH SPRAY

NEW ZINC OXIDE SPRAY!!

Shake well before using

Patent Pending Spray Formula

•   Doctor Recommended
•   Fast / Easy Application
•   Less Irritation For Baby
•   Effective Active Ingredients
•   No Greasy Hands or Fingers

3.38 fl. oz. (100 ml.)

BUM EASE
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76330-100
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (Zinc Oxide)	Zinc Oxide	10 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water
PEANUT OIL
COCONUT ACID
Glycerin
C14-22 ALCOHOLS
C12-20 Alkyl Glucoside
COCO-GLYCERIDES
Phenoxyethanol
Ethylhexylglycerin
Oleic Acid
SILICON DIOXIDE

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:76330-100-10	1 BOTTLE, PUMP ( BOTTLE) in 1 BOX	contains a BOTTLE, PUMP
1		100 mL in 1 BOTTLE, PUMP	This package is contained within the BOX (76330-100-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2011

Labeler - Wake Innovation, LLC (967723029)

Revised: 11/2011 Wake Innovation, LLC