FDA.reportPublic FDA data

SOOTHE Moisturizing Rescue Cream

Manufacturer
Rodan & Fields
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:28

Label at a glance#

ProductSOOTHE Moisturizing Rescue Cream
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema.

Dosage and administration

Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal

Oatmeal 1 %

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens.
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Eau/Water, Ascorbyl Palmitate, Behenic Acid, Butyrospermum Parkii (Shea) Butter, C12-16 Alcohols, Calcium Gluconate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Curcuma Wenyujin/Curcuma Kwangsiensis Rhizome Extract, Cynara Scolymus (Artichoke) Leaf Extract, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Hydrogenated Lecithin, Lecithin, Maltodextrin, Ophiopogon Japonicus Root Extract, Opuntia Ficus-lndica Fruit Extract, Palmitic Acid, Panthenol, Phenoxyethanol, Polysilicone-11, Potassium Sorbate, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Tocopherol, Xanthan Gum, Yeast Extract.

Questions?

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel - 50 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

50 mL/ 1.7 Fl. Oz. U.S.

Colloidal Oatmeal Cream

Principal Display Panel - 50 mL Carton Label
Principal Display Panel - 50 mL Carton Label

Principal Display Panel - 50 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

Colloidal Oatmeal
Skin Protectant

Principal Display Panel - 50 mL Tube Label
Principal Display Panel - 50 mL Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN4
240651colloidal oatmeal 10 MG/ML Topical CreamSCD4
240651Avena sativa 1 % Topical CreamSY4
240651colloidal oatmeal 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2430-12023-12-06C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-22023-12-06C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-32023-12-06C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-12023-07-28C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-22023-07-28C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-32023-07-28C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2430-1SOOTHE Moisturizing Rescue Cream50 mL in 1 TUBECREAM504
14222-2430-1SOOTHE Moisturizing Rescue Cream1 in 1 CARTONCREAM14
14222-2430-2SOOTHE Moisturizing Rescue Cream1 in 1 CARTONCREAM14
14222-2430-2SOOTHE Moisturizing Rescue Cream12 mL in 1 TUBECREAM124
14222-2430-3SOOTHE Moisturizing Rescue Cream2 mL in 1 PACKETCREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2430SOOTHE MOISTURIZING RESCUE CREAM (OATMEAL) CREAM [RODAN & FIELDS]4Current NDC, Legacy NDC, 5 package rows20231207_91163267-c2aa-47b3-b290-d1605536d806.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-243014222-2430-1, 14222-2430-2, 14222-2430-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
ASCORBYL PALMITATEQN83US2B0NIACT
BEHENIC ACIDH390488X0AIACT
SHEA BUTTERK49155WL9YIACT
C12-16 ALCOHOLSS4827SZE3LIACT
CALCIUM GLUCONATESQE6VB453KIACT
N-HEXANOYLSPHINGOSINE038753E78JIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE EOSCR0J8RN66KIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE NGC04977SRJ5IACT
CETEARETH-258FA93U5T67IACT
CETYL ALCOHOL936JST6JCNIACT
CHOLESTEROL97C5T2UQ7JIACT
CURCUMA KWANGSIENSIS ROOT2WSI2681TIIACT
CYNARA SCOLYMUS LEAFB71UA545DEIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MALTODEXTRIN7CVR7L4A2DIACT
OPHIOPOGON JAPONICUS ROOT90PS6JV9GZIACT
PRICKLY PEAR FRUIT18V8PAQ629IACT
PALMITIC ACID2V16EO95H1IACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOOTHE Moisturizing Rescue CreamOATMEALRodan & Fields91163267-c2aa-47b3-b290-d1605536d8062023-12-04WarningsExact identifier
ndc (package): 14222-2430-1
ndc (package): 14222-2430-3
ndc (package): 14222-2430-2
ndc (product): 14222-2430
ndc11 (package): 14222243002
ndc11 (package): 14222243001
ndc11 (package): 14222243003
spl id: 695fafcf-e87a-4e92-8e85-bb1a6b9429d9
spl set id: 91163267-c2aa-47b3-b290-d1605536d806

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.