Pediadermics Eczema 3

Pediadermics Eczema 3
SPL v4
SPL
SPL Set ID af861f0b-4387-6861-e053-2995a90a8bfa
Route
TOPICAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (3.36 g) Oatmeal (0.168 g)
Inactive Ingredients
Meadowfoam Seed Oil Cetostearyl Alcohol Xanthan Gum Carbomer Homopolymer, Unspecified Type Helianthus Annuus Seed Wax Ceramide 1 Jojoba Oil Rice Bran Glyceryl Monostearate Sodium Stearoyl Lactylate Glycerin Cetyl Alcohol Ascorbyl Palmitate Candelilla Wax Propanediol Niacinamide Stearic Acid Water Phytosphingosine Palmitic Acid Biosaccharide Gum-1 Sodium Lauroyl Lactylate Cholesterol Ceramide Np Polyglycerin-3 Caprylyl Glycol Saccharide Isomerate Caprylhydroxamic Acid Ceramide Ap Edetate Disodium Hexanediol Sodium Hydroxide Hyaluronate Sodium Oat Maltodextrin Tocopherol Sodium Pyrrolidone Carboxylate Ophiopogon Japonicus Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Active Ingredients Colloidal oatmeal 0.1% Dimethicone 2%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.

Dosage and Administration

Directions

For best results, follow the rule of "3"

  • Apply liberally to skin at least "3" times a day
  • Apply within "3" minutes of bathing
  • Keep a "3" location supply (Home, On-the-Go and School) !
Description

Active Ingredients Colloidal oatmeal 0.1% Dimethicone 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

Condition worsens

  • Symptoms last more than 2 weeks or clear up and occur again within a few days.
Section 50567-7

When using this product

  • Do not get into eyes
  • Do not apply before bathing or showering
Section 51727-6

Inactive Ingredients

1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum

Section 51945-4

ECZEMA 3 tube artwork

Section 53413-1

Questions?

[email protected]

Section 55105-1

Purpose

Skin protectant

Skin protectant

Section 55106-9

Active Ingredients

Colloidal oatmeal 0.1%

Dimethicone 2%

Section 60561-8

Other information

Store at room temperature.

Section 69718-5

eczema 3

skin barrier repair cream


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.

Dosage and Administration (34068-7)

Directions

For best results, follow the rule of "3"

  • Apply liberally to skin at least "3" times a day
  • Apply within "3" minutes of bathing
  • Keep a "3" location supply (Home, On-the-Go and School) !
Warnings and Precautions (34071-1)

Warnings

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

Condition worsens

  • Symptoms last more than 2 weeks or clear up and occur again within a few days.
Section 50567-7 (50567-7)

When using this product

  • Do not get into eyes
  • Do not apply before bathing or showering
Section 51727-6 (51727-6)

Inactive Ingredients

1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum

Section 51945-4 (51945-4)

ECZEMA 3 tube artwork

Section 53413-1 (53413-1)

Questions?

[email protected]

Section 55105-1 (55105-1)

Purpose

Skin protectant

Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Colloidal oatmeal 0.1%

Dimethicone 2%

Section 60561-8 (60561-8)

Other information

Store at room temperature.

Section 69718-5 (69718-5)

eczema 3

skin barrier repair cream


Advanced Ingredient Data


Raw Label Data

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