Initial Drug Listing - Roycederm Eczema Relief Cream

Initial Drug Listing - Roycederm Eczema Relief Cream
SPL v1
SPL
SPL Set ID 3e09f000-01d2-0d21-e063-6294a90ac548
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1.13 g)
Inactive Ingredients
Aqua Glycerin Butylene Glycol .alpha.-tocopherol Acetate, D- Butyrospermum Parkii (shea) Butter Hydroxyacetophenone Asiaticoside Aloe Barbadensis Leaf Chrysanthellum Indicum Top Ectoin Maltodextrin Cetearyl Glucoside Panthenol Houttuynia Cordata Flowering Top Centella Asiatica Triterpenoids Oat N-carboxymethylchitosan Ceramide 6 Ii Purslane Paeonia Suffruticosa Root Sodium Polyglutamate (200000 Mw) Madecassoside Camellia Sinensis Leaf Sodium Hyaluronate Cetearyl Alcohol Squalane Camellia Japonica Seed Oil Simmondsia Chinensis (jojoba) Seed Oil Opuntia Streptacantha Stem 1,2-hexanediol Ceramide 1 Tremella Fuciformis Whole Scutellaria Baicalensis Root Allantoin Ceramide 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

Colloidal Oatmeal 1%


Medication Information

Warnings and Precautions

For external use only

Indications and 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.
Dosage and Administration

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

Description

Colloidal Oatmeal 1%

Section 50565-1

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

Section 50567-7

do not get into eyes

Section 50569-3

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

Section 51727-6

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

Section 51945-4

Section 53413-1
Section 55105-1

Skin Protectant

Section 55106-9

Colloidal Oatmeal 1%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)
  • 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.
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

do not get into eyes

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Colloidal Oatmeal 1%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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