EVEREDEN INTENSIVE ECZEMA BALM- colloidal oatmeal ointment

Evereden Intensive Eczema Balm by

Drug Labeling and Warnings

Evereden Intensive Eczema Balm by is a Otc medication manufactured, distributed, or labeled by Eden Brands Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

ACTIVE INGREDIENT

Colloidal Oatmeal 2%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

USES:

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

• Eczema
• Rashes

WARNINGS

For external use only

WHEN USING

When using this product: Do not get into eyes

STOP USE

Stop use and ask a doctor if:

• Conditions worsen
• 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.

DOSAGE & ADMINISTRATION

Directions: Use as needed.

OTHER SAFETY INFORMATION

Other Information: Store product at room temperature

INACTIVE INGREDIENT

Helianthus Annuus (Sunflower) Seed Oil, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Vegetable Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Butter, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Spent Grain Wax, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Phaeodactylum Tricornutum Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Argania Spinosa Kernel Oil, Hydrogenated Vegetable Oil, Beta-Sitosterol, Boswellia Serrata Gum, Oleic Acid, Linoleic Acid, Phytosterols, Phospholipids, Glyceryl Behenate, Saccharomyces/Zinc Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Iron Ferment, Saccharomyces/Silicon Ferment, Saccharomyces/Copper Ferment, Polyglyceryl-4 Isostearate, Lecithin, Polyglyceryl-3 Diisostearate, Ceramide NG, Ceramide NP, Water (Aqua), Rosmarinus Officinalis (Rosemary) Leaf Extract, Quercetin, Tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVEREDEN INTENSIVE ECZEMA BALM 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CANDELILLA WAX (UNII: WL0328HX19)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
OCTYLDODECANOL (UNII: 461N1O614Y)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
TOCOPHEROL (UNII: R0ZB2556P8)
CERAMIDE NP (UNII: 4370DF050B)
ROSEMARY (UNII: IJ67X351P9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
SQUALANE (UNII: GW89575KF9)
CARDIOSPERMUM HALICACABUM LEAF (UNII: 8W2E41J67L)
CORN OIL (UNII: 8470G57WFM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA BUTTER (UNII: XIA46H803R)
SHEA BUTTER (UNII: K49155WL9Y)
ARGAN OIL (UNII: 4V59G5UW9X)
OLEIC ACID (UNII: 2UMI9U37CP)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CERAMIDE NG (UNII: C04977SRJ5)
QUERCETIN (UNII: 9IKM0I5T1E)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-109-21	1 in 1 CARTON	11/18/2024
1		45 g in 1 JAR; 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	11/18/2024

Labeler - Eden Brands Inc. (081062339)