ZINC OXIDE DIAPER RASH- zinc oxide diaper rash spray spray 
Neobourne Pharma Lp

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 Spray

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin (or minor skin irritation) due to diaper rash and helps protect from wetness

Warnings

For external use only

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens

■ symptoms last more than 7 days or clear up and occur again within a few days

Keep out of the reach of children

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

Directions

■ change wet and soiled diapers promptly

■ cleanse the diaper area, and allow to dry

■ shake well before use

■ spray 4-6 inches from skin

■ apply spray 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 between 15°C and 25°C (59°F and 77°F)

■ do not use if plastic packaging surrounding spray bottle and nozzle is missing or broken

Inactive Ingredients

aloe barbadensis leaf extract, aloe barbadensis leaf juice, calendula officinalis flower extract, canola oil, cellulose, cellulose gum, distilled water, glycerin, glyceryl caprylate, glyceryl undecylenate, microcrystalline cellulose, sorbitol, sucrose dilaurate, sucrose laurate, sucrose trilaurate, tocopherols

Questions?

973-847-5906

You may also report serious side effects to this phone number

Additional information listed on other panels

Distributed by Neobourne Pharma LP

Montreal, Quebec, Canada H3Z 2P9

Made in Canada

Principal Display Panel

Neobourne Pharma

Diaper Rash Spray

10% Zinc Oxide

Skin Protectant

● Non-touch

● Quick dry

● No mess

Shake well before using

6 FL OZ (180ml)

Principal Display

ZINC OXIDE DIAPER RASH 
zinc oxide diaper rash spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69276-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
SORBITOL (UNII: 506T60A25R)  
CANOLA OIL (UNII: 331KBJ17RK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SUCROSE LAURATE (UNII: 05Q7CD0E49)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69276-110-0660 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/16/201511/29/2017
2NDC:69276-110-18180 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/16/201511/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/16/201511/29/2017
Labeler - Neobourne Pharma Lp (202909586)

Revised: 11/2017
 
Neobourne Pharma Lp