AVENE XERACALM ECZEMA CALMING RELIEF BALM- colloidal oatmeal cream 
Pierre Fabre USA Inc.

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Avene XERACALM Eczema Calming Relief Balm

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

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

Warnings

For external use only.

When using this product

When using this product - do not get into eyes

Stop use and ask a doctor

Stop use and ask a doctor if

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water (aqua), Propanediol, Caprylic/capric triglyceride, Glyceryl stearate, Cetearyl alcohol, Cetyl alcohol, Glycerin, 1,2 Hexanediol, Arginine, Caprylyl glycol, Ceramide NP, Citric acid, Maltodextrin, Oenothera biennis (evening primrose) oil, Ophiopogon japonicus root extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Sodium benzoate, Sodium hydroxide, Sorbitan isostearate, Tocopherol.

Questions?

1-866-41-AVENE (28363).

Tube 337123

Tube 337123

AVENE XERACALM ECZEMA CALMING RELIEF BALM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-777
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
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ARGININE (UNII: 94ZLA3W45F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACONITIC ACID (UNII: 93371T1BXP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
POLYACRYLATE-13 (UNII: FS2D4T67EA)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CERAMIDE NP (UNII: 4370DF050B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-777-01100 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
2NDC:64760-777-021 in 1 BOX06/03/2024
25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/01/2024
Labeler - Pierre Fabre USA Inc. (117196928)
Registrant - Pierre Fabre USA Inc. (117196928)

Revised: 11/2024
Document Id: 26443c1f-2af2-eaf3-e063-6294a90acf57
Set id: 1315f006-0e96-2074-e063-6394a90a6037
Version: 3
Effective Time: 20241106
 
Pierre Fabre USA Inc.