Babo Botanicals Sensitive Baby Healing Ointment

Manufacturer
Babo Botanicals, Inc.
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:57:24

Label at a glance#

ProductBabo Botanicals Sensitive Baby Healing
Active ingredientOATMEAL
Label structure10 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. Children under 3 months: ask a doctor.

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
  • poison ivy ,oak, or sumac
  • insect bites

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

  • conditions 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 swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed.
  • Children under 3 months: ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Olea Europoaea (Olive) Fruit Oil*, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Theobroma Cacao (Cocoa) Seed Butter*, Rosmarinus Officinalis (Rosemary) Leaf Extract*.

*Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

Company Information

SPL UNCLASSIFIED SECTION

Dist: by Babo Botanicals, Inc.

60 East 56th Street

New York, NY 10022

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545142colloidal oatmeal 1 % Topical OintmentPSN1
1545142colloidal oatmeal 0.01 MG/MG Topical OintmentSCD1
1545142colloidal oatmeal 1 % Topical OintmentSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8655-1Babo Botanicals Sensitive Baby Healing113 g in 1 JAROINTMENT1131
79265-8655-1Babo Botanicals Sensitive Baby Healing1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8655BABO BOTANICALS SENSITIVE BABY HEALING (COLLOIDAL OATMEAL) OINTMENT [BABO BOTANICALS, INC.]1Current NDC, 2 package rows20231024_08659a5c-2d10-2f98-e063-6394a90a7760.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-865579265-8655-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
ndc (package): 79265-8655-1
ndc (product): 79265-8655
ndc11 (package): 79265865501
spl id: 0865929f-e8c6-3f68-e063-6294a90ac71c
spl set id: 08659a5c-2d10-2f98-e063-6394a90a7760

Reported adverse events (FAERS/openFDA)#

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