Whipped Gel

Manufacturer
OCEAN OLIVE LLC
Effective date
2024-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:59

Label at a glance#

ProductWhipped Gel
Active ingredientOATMEAL
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OCEAN OLIVE

Whipped Gel

Nourishing Eczema Spot Treatment

Skin Protectant

Accepted National Eczema Association

1.7 oz / 50 ml

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.1%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to eczema

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • conditions worsen
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed.

INACTIVE INGREDIENT SECTION

Water, Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Cetearyl Olivate, Sorbitan Olivate, Butyspermum Parkii (Shea) Butter, Sodium Acrylates Copolymer, Glycerin, Inulin, Fucus Vesiculosis (Bladderwrack) Extract, Cetyl Palmitate, Sorbitan Palmitate, Lecithin, Allantoin, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Lactic Acid, Sclerotium Gum, Cyanocobalamin, Pullulan, Silica.

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 1-800-484-9354 M-F 8am-5pm CST

www.ocean-olive.com

RECENT MAJOR CHANGES SECTION

Mislabeled section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ocean Olive Whipped GelOcean Olive Whipped Gel

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84293-010-01Whipped Gel50 g in 1 CONTAINERGEL501
84293-010-02Whipped Gel1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84293-010WHIPPED GEL (COLLOIDAL OATMEAL) GEL [OCEAN OLIVE LLC]1Current NDC, 2 package rows20240924_222b381c-665e-177d-e063-6394a90a3306.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84293-01084293-010-01, 84293-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
ndc (package): 84293-010-02
ndc (package): 84293-010-01
ndc (product): 84293-010
ndc11 (package): 84293001002
ndc11 (package): 84293001001
spl id: 222b381c-665f-177d-e063-6394a90a3306
spl set id: 222b381c-665e-177d-e063-6394a90a3306

Reported adverse events (FAERS/openFDA)#

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