XERBEX ECZEMA CREAM- colloidal oatmeal cream 
Xerbal USA LLC

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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Xerbex Eczema Cream

Drug Facts

Active IngredientsPurpose
Colloidal Oatmeal 1%   Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

Warnings

For external use only

Do not use

  • if allergic to any ingredients of this product

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • side effects occur. You may report side effects to FDA at 1–800–FDA–1088.

Keep out of reach of children to avoid accidental poisoning .

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

Directions

Other information

Inactive ingredients

Arlacel 165, Cannabidiol (CBD), Carbomer, Ceteareth-20, Cetyl alcohol, Deionized water, Dimethicone, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Phenyl trimethicone, Stearic acid, Sorbitan stearate, Tromethamine, Xanthan Gum

Questions?

Pacific Time 8:00am to 5:00pm

1-626-822-8211

PRINCIPAL DISPLAY PANEL - 7.3 oz (206 g)

NDC.No : 81021-011-01

Xerbex Eczema Cream

Skin Protectant

Xerbex

Xerbex Eczema Cream

XERBEX ECZEMA CREAM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81021-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TROMETHAMINE (UNII: 023C2WHX2V)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81021-011-011 in 1 BOX04/01/2021
1206 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2021
Labeler - Xerbal USA LLC (117731081)

Revised: 4/2021
Document Id: bf074850-bc6d-56c1-e053-2995a90ad12f
Set id: 01833c1d-6bf9-4c25-8f6c-3ba132f1e4c6
Version: 1
Effective Time: 20210402
 
Xerbal USA LLC