FDA.reportPublic FDA data

Avene XERACALM Eczema Calming Relief Balm

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:34:48

Label at a glance#

ProductAvene XERACALM Eczema Calming Relief Balm
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

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

Dosage and administration

Apply as needed. For targeted areas on body, face and hands.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

  • Eczema
  • Rashes

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product - do not get into eyes

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed. For targeted areas on body, face and hands.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-866-41-AVENE (28363).

Tube 337123

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube 337123Tube 337123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3
240651Avena sativa 1 % Topical CreamSY3
240651colloidal oatmeal 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64760-777-01Avene XERACALM Eczema Calming Relief Balm100 g in 1 TUBECREAM1003
64760-777-02Avene XERACALM Eczema Calming Relief Balm5 g in 1 TUBECREAM53
64760-777-02Avene XERACALM Eczema Calming Relief Balm1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-777AVENE XERACALM ECZEMA CALMING RELIEF BALM (COLLOIDAL OATMEAL) CREAM [PIERRE FABRE USA INC.]3Current NDC, 3 package rows20241108_1315f006-0e96-2074-e063-6394a90a6037.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-77764760-777-01, 64760-777-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SODIUM BENZOATEOJ245FE5EUIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
WATER059QF0KO0RIACT
OATMEAL8PI54V663YACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARGININE94ZLA3W45FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PROPANEDIOL5965N8W85TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
ACONITIC ACID93371T1BXPIACT
MALTODEXTRIN7CVR7L4A2DIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
POLYACRYLATE-13FS2D4T67EAIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
OPHIOPOGON JAPONICUS ROOT90PS6JV9GZIACT
TOCOPHEROLR0ZB2556P8IACT
CERAMIDE NP4370DF050BIACT
SODIUM HYDROXIDE55X04QC32IIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avene XERACALM Eczema Calming Relief BalmCOLLOIDAL OATMEALPierre Fabre USA Inc.1315f006-0e96-2074-e063-6394a90a60372024-11-06WarningsExact identifier
ndc (package): 64760-777-02
ndc (package): 64760-777-01
ndc (product): 64760-777
ndc11 (package): 64760077701
ndc11 (package): 64760077702
spl id: 26443c1f-2af2-eaf3-e063-6294a90acf57
spl set id: 1315f006-0e96-2074-e063-6394a90a6037

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.