Superbalm Healing Ointment for Babies

Manufacturer
Era Organics, Inc.
Effective date
2025-11-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:18:32

Label at a glance#

ProductSuperbalm
Active ingredientOATMEAL
Label structure9 sections

Label contents#

Full prescribing information#

Superbalm Healing Ointment for Babies

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Superbalm Healing Ointment for Babies

INACTIVE INGREDIENT SECTION

Castor (Ricinus Communis) Oil*, Chickweed (Stellaria Media)* & Chamomile (Matricaria Recutita)* Infusion in Sunflower (Helianthus Annuus) Oil*, Beeswax (Cera Alba), Cocoa Butter (Theobroma Cacao), Vegetable Glycerin*, Coconut (Cocos Nucifera) Oil*, Calendula (Calendula Officinalis) Flower Extract*, Tapioca Starch*, Avocado (Persea Gratissima) Oil*, Rosehip (Rosa Canina) Oil*, Arnica (Arnica Montana) Oil*, Non-GMO Vitamin E from Sunflowers*, Organic Ingredients.

Superbalm Healing Ointment for Babies

OTC - PURPOSE SECTION

Skin Protectant

Superbalm Healing Ointment for Babies

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.

Superbalm Healing Ointment for Babies

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens - symptoms last more than 7 days or clear up and occur again within a few days.

Superbalm Healing Ointment for Babies

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Superbalm Healing Ointment for Babies

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema - Rashes

Superbalm Healing Ointment for Babies

WARNINGS SECTION

For external use only. When using this product do not get into eyes

Superbalm Healing Ointment for Babies

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Superbalm Healing Ointment for BabiesSuperbalm Healing Ointment for Babies

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130712411779160GTIN-13: 0712411779160
EAN-13: 0712411779160
GTIN-12: 712411779160
UPC-A: 712411779160
GTIN storage (14 digits): 00712411779160
Superbalm - Healing Ointment for Babies.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72400-300-02Superbalm57 g in 1 JARSALVE574
72400-300-04Superbalm113 g in 1 JARSALVE1134
72400-300-08Superbalm227 g in 1 JARSALVE2274

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72400-30072400-300-02, 72400-300-04, 72400-300-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
ndc (package): 72400-300-04
ndc (package): 72400-300-02
ndc (package): 72400-300-08
ndc (product): 72400-300
ndc11 (package): 72400030004
ndc11 (package): 72400030008
ndc11 (package): 72400030002
spl id: 44994dfb-94c0-115b-e063-6294a90adff4
spl set id: f5298e5e-583d-d74c-e053-2995a90affb5

Reported adverse events (FAERS/openFDA)#

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