FDA.reportPublic FDA data

Calming Itch & Irritation Lotion, Oxygen

Manufacturer
Better Planet Brands LLC
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:19:15

Label at a glance#

ProductCalming Itch and Irritation
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes • eczema poison ivy, oak, or sumac • insect bites

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to: rashes

• eczema

poison ivy, oak, or sumac

• insect bites

Warnings

WARNINGS SECTION

For external use

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask 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 or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

OTHER SAFETY INFORMATION

Remove quality seal.

Do not use if quality seal is broken. Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID.

Questions?

OTC - QUESTIONS SECTION

Call toll-free 877.902.2873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1591951colloidal oatmeal 2 % Topical LotionPSN5
1591951colloidal oatmeal 20 MG/ML Topical LotionSCD5
1591951colloidal oatmeal 2 % Topical LotionSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54136-183-24Calming Itch and Irritation239 g in 1 TUBELOTION2395

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54136-18354136-183-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
SQUALANEGW89575KF9IACT
TOCOPHEROLR0ZB2556P8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CHIA SEED OILMC2LH51BO7IACT
SHEA BUTTERK49155WL9YIACT
CETEARYL OLIVATE58B69Q84JOIACT
GLYCERYL LAURATEY98611C087IACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERINPDC6A3C0OXIACT
QUINOA OILM437LS0K52IACT
SORBITAN OLIVATEMDL271E3GRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
COCO-GLYCERIDESISE9I7DNUGIACT
SODIUM LEVULINATEVK44E1MQU8IACT
COCOA BUTTER512OYT1CRRIACT
XANTHAN GUMTTV12P4NEEIACT
OATMEAL8PI54V663YACTIB

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
Calming Itch and IrritationCOLLOIDAL OATMEALBetter Planet Brands LLC1dd7e712-56a4-86c0-e063-6294a90a75cd2025-12-03WarningsExact identifier
ndc (package): 54136-183-24
ndc (product): 54136-183
ndc11 (package): 54136018324
spl id: 45132ba3-8160-c77a-e063-6294a90a0868
spl set id: 1dd7e712-56a4-86c0-e063-6294a90a75cd

Reported adverse events (FAERS/openFDA)#

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