Bum Ease
FDA Label NDC 76330-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wake Innovation, Llc for the product Bum Ease (NDC 76330-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and contact a doctor if:, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

• 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


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.)

* Please review the disclaimer below.