Intensive Eczema Balm

Intensive Eczema Balm
SPL v1
SPL
SPL Set ID 2243d4ca-5ca4-54d0-e063-6394a90a3940
Route
TOPICAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (2 g)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Candelilla Wax Ribes Nigrum Seed Oil Lecithin, Sunflower Phaeodactylum Tricornutum Helianthus Annuus Seed Wax Octyldodecanol Isostearyl Alcohol Sunflower Oil Unsaponifiables Polyglyceryl-4 Isostearate Water C18-38 Alkyl Hydroxystearoyl Stearate .beta.-sitosterol Indian Frankincense Tocopherol Ceramide Np Rosemary Sunflower Oil Jojoba Oil Squalane Cardiospermum Halicacabum Leaf Corn Oil Medium-chain Triglycerides Jojoba Butter Shea Butter Argan Oil Oleic Acid Linoleic Acid Omega-3 Fatty Acids Glyceryl Dibehenate Polyglyceryl-3 Diisostearate Ceramide Ng Quercetin Phytosteryl/isostearyl/cetyl/stearyl/behenyl Dimer Dilinoleate Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-18

Description

Colloidal Oatmeal 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

USES:

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

  • Eczema
  • Rashes
Dosage and Administration

Directions: Use as needed.

Description

Colloidal Oatmeal 2%

Section 50565-1

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

Section 50566-9

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
Section 50567-7

When using this product: Do not get into eyes

Section 51727-6

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

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Colloidal Oatmeal 2%

Section 60561-8

Other Information: Store product at room temperature

Section 69718-5


Structured Label Content

Indications and Usage (34067-9)

USES:

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

  • Eczema
  • Rashes
Dosage and Administration (34068-7)

Directions: Use as needed.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product: Do not get into eyes

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Colloidal Oatmeal 2%

Section 60561-8 (60561-8)

Other Information: Store product at room temperature

Section 69718-5 (69718-5)


Advanced Ingredient Data


Raw Label Data

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