AVENE XERACALM ECZEMA CALMING RELIEF BALM- colloidal oatmeal cream

Avene XERACALM Eczema Calming Relief Balm by

Drug Labeling and Warnings

Avene XERACALM Eczema Calming Relief Balm by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

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

• Eczema
• Rashes

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

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

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

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

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

INGREDIENTS AND APPEARANCE

AVENE XERACALM ECZEMA CALMING RELIEF BALM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-777
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-777-01	100 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2024
2	NDC: 64760-777-02	1 in 1 BOX	06/03/2024
2		5 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 Drug	M016	05/01/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)