ROYCEDERM ECZEMA RELIEF CREAM- colloidal oatmeal 1% cream

RoyceDerm Eczema Relief Cream by

Drug Labeling and Warnings

RoyceDerm Eczema Relief Cream by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Colloidal Oatmeal 1%

PURPOSE

Skin Protectant

DOSAGE & ADMINISTRATION

Temporarily protects and helps relieve minor skin irritationand itching due to Eczema and Rashes

WARNINGS

For external use only

do not get into eyes

condition worsens or symptoms last morethan 7 days or clear up and occur again within a few days

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Centerright away.(1-800-222-1222)

INDICATIONS & USAGE

• Conduct a patch test on a small area of skin to checkfor sensitivity or allergic reaction.
• Apply as needed to affectedarea.
• Use 1-2 times daily or as directed by a doctor.
• For childrenunder 6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

store at room temperature. Avoid excessive heat and direct sunlight.

INACTIVE INGREDIENT

Aqua, Butylene Glycol, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Camellia Japonica Seed Oil,Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Cetearyl Glucoside, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Ceramide 1, Ceramide 3, Ceramide 6 ll, Ectoin,Carboxymethyl Chitosan, Camellia Sinensis Leaf Extract, Tremella Fuciformis Polysaccharide, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Maltodex-trin, Chrysanthellum Indicum Extract, Houttuynia Cordata ExtractOpuntia Streptacantha Stem Extract, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Allantoin, Sodium Hyaluronate, Sodium Polyglutamate, Centella Asiatica Extract, Madecassoside, Asiaticoside

QUESTIONS

Email service@roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM ECZEMA RELIEF CREAM 
colloidal oatmeal 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.13 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ASIATICOSIDE (UNII: PKO39VY215)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)
ECTOIN (UNII: 7GXZ3858RY)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PANTHENOL (UNII: WV9CM0O67Z)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
OAT (UNII: Z6J799EAJK)
N-CARBOXYMETHYLCHITOSAN (UNII: 5R88W82CC6)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PURSLANE (UNII: M6S840WXG5)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
SODIUM POLYGLUTAMATE (200000 MW) (UNII: LN8DW52UVL)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CERAMIDE 1 (UNII: 5THT33P7X7)
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE 3 (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-010-01	113 g in 1 CARTON; Type 0: Not a Combination Product	09/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/30/2025

Labeler - RoyceDerm LLC (130329531)

Registrant - RoyceDerm LLC (130329531)