XERBEX ECZEMA CREAM- colloidal oatmeal cream

Xerbex Eczema Cream by

Drug Labeling and Warnings

Xerbex Eczema Cream by is a Otc medication manufactured, distributed, or labeled by Xerbal USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Colloidal Oatmeal 1%	Skin Protectant

Uses

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

• rashes
• eczema
• poison ivy, oak, or sumac
• insect bites

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

• Apply as needed

Other information

• store at room temperature, 20 to 25 oC(68 to 77 oF)

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

INGREDIENTS AND APPEARANCE

XERBEX ECZEMA CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81021-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81021-011-01	1 in 1 BOX	04/01/2021
1		206 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2021

Labeler - Xerbal USA LLC (117731081)