The05-barrier Therapy Skin Protectant Cream

The05-barrier Therapy Skin Protectant Cream
SPL v9
SPL
SPL Set ID ffc39cf2-617e-1e81-e053-6294a90a075f
Route
TOPICAL
Published
Effective Date 2023-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 g)
Inactive Ingredients
Ceteareth-25 Soy Sterol Caprooyl Phytosphingosine C10-18 Triglycerides Allantoin Adenosine Ceramide Ap Ceramide Eos Tetrasodium Glutamate Diacetate Omega-3 Fatty Acids Ceramide Np Glycerin Shea Butter Sodium Stearoyl Glutamate Cetyl Alcohol Dimethicone Phenoxyethanol .alpha.-tocopherol Acetate Sorbitan Olivate N-hexanoylsphingosine Cetearyl Olivate Ceramide 2 Water Ceramide 1 Cholesterol Behenic Acid Soybean Oil Medium-chain Triglycerides Safflower Oil Carbomer Homopolymer, Unspecified Type Hydrogenated Palm Glycerides Hydrogenated Palm Kernel Glycerides Ethylhexylglycerin Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-23 Until 2026-08-31

Description

Skin Protectant

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Skin Protectant

Uses

Temporarily protects and helps releive minor skin irritation and itching due:

rashes

eczema

poison ivy, oak, or sumac

insect biktes

Warnings

Fox external use only.

When using this product do not get into eyes

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

Directions

Apply as needed.

Questions?

Visit prequelskin.com

Active Ingredients

Colloidal Oatmeal 1.00%

Inactive Ingredients

Water (Aqua), Carthamus Tinctorius Seed Oil, Cetyl Alcohol, Glycerin, Butyrospermum Parkii Butter, Caprylic/Capric Triglyceride, Dimethicone, C10-18 Trigylcerides, Allantoin, Adenosine, Cetearyl Olivate, Sorbitan Olivate, Ceramide AP, Ceramide EOS, Ceramide EOP, Ceramide NP, Ceramide NS, Cholesterol, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Glycolipids, Phospholipids, Sodium Stearoyl Glutamate, Behenic Acide, Ceteareth-25, Glycine Soja Sterols, Hydrogenated Palm Glycerides, Hydrogenated Palm Kernel Glycerides, Carbomer, Phenoxyethanol, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

Principal Display Panel

Keep Out of Reach of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.

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


Structured Label Content

Uses

Temporarily protects and helps releive minor skin irritation and itching due:

rashes

eczema

poison ivy, oak, or sumac

insect biktes

Purpose

Skin Protectant

Warnings

Fox external use only.

When using this product do not get into eyes

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

Directions

Apply as needed.

Questions?

Visit prequelskin.com

Active Ingredients

Colloidal Oatmeal 1.00%

Inactive Ingredients

Water (Aqua), Carthamus Tinctorius Seed Oil, Cetyl Alcohol, Glycerin, Butyrospermum Parkii Butter, Caprylic/Capric Triglyceride, Dimethicone, C10-18 Trigylcerides, Allantoin, Adenosine, Cetearyl Olivate, Sorbitan Olivate, Ceramide AP, Ceramide EOS, Ceramide EOP, Ceramide NP, Ceramide NS, Cholesterol, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Glycolipids, Phospholipids, Sodium Stearoyl Glutamate, Behenic Acide, Ceteareth-25, Glycine Soja Sterols, Hydrogenated Palm Glycerides, Hydrogenated Palm Kernel Glycerides, Carbomer, Phenoxyethanol, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

Principal Display Panel

Keep Out of Reach of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away. (Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.)

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


Advanced Ingredient Data


Raw Label Data

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