PREQUEL BARRIER THERAPY RICH SKIN PROTECTANT CREAM- skin protectant cream cream

Prequel Barrier Therapy Rich Skin Protectant Cream by

Drug Labeling and Warnings

Prequel Barrier Therapy Rich Skin Protectant Cream by is a Otc medication manufactured, distributed, or labeled by The Center Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Skin Protectant

Active Ingredients

Colloidal Oatmeal 1.0%

Uses

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

-rashes

-eczema

-poison ivy, oak, or sumac

-insect bites

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

If swallowed, get medial help or contact a Poison Control Center right away.

Keep out of reach of children.

Keep out of reach of children.

Directions

Apply as needed.

Inactive ingredients

Water (Aqua), Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, C10-18 Triglycerides, Sorbitan Olivate, Adenosine, Allantoin, Behenyl/Oleyl Behenate/Oleate Esters, Ceramide NP, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Cholesterol, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Phospholipids, Glycolipids, Sodium Stearoyl Glutamate, Behenic Acid, Ceteareth-25, Glycine Soja (Soybean) Oil, Glycine Soja (Soybean) Sterols, Ascorbyl Palmitate, Tocopherol, Lecithin, Glyceryl Stearate, Glyceryl Oleate, Carbomer, hydroxyacetophenone, Phenoxyethanol, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Sodium Chloride, Lactic Acid, Sodium Hydroxide, Citric Acid.

Other Information

Store in controlled temperatures (4-20C/39-68F). Keep in a dark and dry place,

Questions?

Visit prequelskin.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

PREQUEL BARRIER THERAPY RICH SKIN PROTECTANT CREAM 
skin protectant cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CERAMIDE AP (UNII: F1X8L2B00J)
LACTIC ACID (UNII: 33X04XA5AT)
ADENOSINE (UNII: K72T3FS567)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
CARBOMER (UNII: 0A5MM307FC)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CERAMIDE NS (UNII: V7M2259XJM)
CAPROOYL SPHINGOSINE (UNII: 038753E78J)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CERAMIDE NP (UNII: 4370DF050B)
BEHENIC ACID (UNII: H390488X0A)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETEARETH-25 (UNII: 8FA93U5T67)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CERAMIDE EOS (UNII: CR0J8RN66K)
GLYCINE SOJA (SOYBEAN) STEROLS (UNII: PL360EPO9J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-100-01	1 in 1 PACKAGE	07/10/2025
1		296 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	07/10/2025

Labeler - The Center Brands, LLC (076228814)