Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 765a4d0d-a861-4cfc-a87e-bc6b9a35862a
Route
TOPICAL
Published
Effective Date 2011-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 g)
Inactive Ingredients
Water Peanut Oil Coconut Acid Glycerin C14-22 Alcohols C12-20 Alkyl Glucoside Coco-glycerides Phenoxyethanol Ethylhexylglycerin Oleic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-01

Description

Zinc Oxide 10%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 10%

Uses

• Helps treat and prevent diaper rash

• Protects chafed skin due to diaper rash and helps seal out wetness

Section 50565-1

• Keep this and all drugs out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Warnings

• For external use only.

• When using this product avoid contact with eyes.



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

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.)

Active Ingredient

Zinc Oxide 10%

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

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.




Structured Label Content

Uses

• Helps treat and prevent diaper rash

• Protects chafed skin due to diaper rash and helps seal out wetness

Section 50565-1 (50565-1)

• Keep this and all drugs out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Purpose

Skin Protectant

Warnings

• For external use only.

• When using this product avoid contact with eyes.



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

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.)

Active Ingredient

Zinc Oxide 10%

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

Stop Use and Contact A Doctor If: (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.




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)