DESERT ESSENCE DONT BE RASH DIAPER CREAM- zinc oxide  cream 
Autumn Harp, Inc.

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.

----------

Desert Essence Dont Be Rash Diaper Cream

Active Ingredient

Zinc Oxide 12%

Purpose:

Skin Protectant

Uses:

• Helps treat and prevent diaper rash

• Helps seal out wetness

• Protects chafed skin due to diaper rash

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 reach of children. If swallowed, get medical help or contact a physician.

Directions for Use:

• Apply to clean, dry skin by massaging a thick layer on baby's bottom. 

Inactive Ingredients:

Ricinus Communis (Castor) Seed Oil*, Lanolin, Beeswax (Cera Alba)*, Silica

* Certified Organic

Principal Display Panel

Image Componentscomponent artwork

DESERT ESSENCE DONT BE RASH DIAPER CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0338
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
LANOLIN (UNII: 7EV65EAW6H)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0338-189 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/09/2011
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0338)

Revised: 5/2014
Document Id: 086b6d24-c552-4eb2-a405-ff1be677af5f
Set id: c120406d-ef09-4d0c-9a3e-f8d0886378ac
Version: 1
Effective Time: 20140519
 
Autumn Harp, Inc.