GENTLE ECZEMA BALM - colloid oatmeal stick 
Naterra International 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.

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Active Ingredient: Colloid Oatmeal USP (0.8%)

Purpose : Skin Protectant

           

Warnings: For external use only

Stop use and ask doctor if * condition worsens, * symptoms last more than 7 days or clear up and occur again within a few days.







Uses :

* Temporary protects and helps relieve minor skin irritation and itching due to * eczema


Direction ; Apply as needed


Fragrance


Image of Label

GENTLE ECZEMA BALM 
colloid oatmeal stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45765-5142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal0.112 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CERESIN (UNII: Q1LS2UJO3A)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45765-5142-014 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34710/12/2010
Labeler - Naterra International INC. (879056786)
Registrant - Beautymanufacturing Solutions Corperation (783200723)

Revised: 10/2011
Document Id: 7eb7f345-33c5-41d7-bc5d-c3d2e8b3ce77
Set id: eb169720-9cdb-4649-917f-3c44c0d16db2
Version: 1
Effective Time: 20111012
 
Naterra International INC.