FDA.reportPublic FDA data

8565 & 8765 Babo Sensitive Baby All Natural Healing Ointment

Manufacturer
Babo Botanicals, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:43:30

Label at a glance#

ProductBabo Sensitive Baby All Natural Healing
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • poison ivy and • insect bites.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1% Skin protectant

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 and • insect bites.

Warnings

WARNINGS SECTION

For external use only.When using this product • Do not get into eyes Stop use and ask a doctor if• Conditions worsens• symptoms last more than 7 days or clear up and occur again within a few days. - In case of accidental ingestion, contact a physician or a Poison Control Center immediately.

When using this product

OTC - WHEN USING SECTION

When using this product Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if• Conditions worsens• symptoms last more than 7 days or clear up and occur again within a few days. - In case of accidental ingestion, contact a physician or a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax*, Bisabolol*, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Extract*, Eucalyptus Globulus Leaf Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil*, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Mentha Piperita (Peppermint) Oil*, Nasturtium Officinale (Watercress) Flower/leaf Extract*, Olea Europaea (Olive) Fruit Oil*, Pueraria Lobata (Kudzu) Root Extract*, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Rosmarinus Officinalis (Rosemary) Leaf Oil*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*.

*Certified Organic Ingredient

Distributed by

SPL UNCLASSIFIED SECTION

Dist: by Babo Botanicals, Inc.

60 East 56th Street

New York, NY 10022

Information Panel

SPL UNCLASSIFIED SECTION

This waterless ointment provides head to toe relief for itchy skin and minor skin irritations, such as eczema and insect bites.

Packed with pure goodness and vitamin rich oils that protect and lock in moisture.

gluten, soy & dairy free

paraben & phthalate free

dermatologist tested

preservative free

steroid free

mineral oil free

PEDIATRICIAN TESTED

DERMATOLOGIST TESTED

HYPOALLERGENIC

79265-8565 Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79265-8565-0 113 g Outer Packaging Box

85658565

79265-8765 Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79265-8765-0 Principal Display Panel

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545142colloidal oatmeal 1 % Topical OintmentPSN8
1545142colloidal oatmeal 0.01 MG/MG Topical OintmentSCD8
1545142colloidal oatmeal 1 % Topical OintmentSY8

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
79265-8565-0Babo Sensitive Baby All Natural Healing1 in 1 BOXOINTMENT18
79265-8565-1Babo Sensitive Baby All Natural Healing113 g in 1 JAROINTMENT1138
79265-8765-0Babo Sensitive Baby All Natural Healing1 in 1 BOXOINTMENT18
79265-8765-1Babo Sensitive Baby All Natural Healing113 g in 1 JAROINTMENT1138

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8565BABO SENSITIVE BABY ALL NATURAL HEALING (SKIN PROTECTANT) OINTMENT [BABO BOTANICALS, INC.]8Legacy NDC, 2 package rows20241215_b3e55f57-3d9d-2a0e-e053-2995a90a4c58.zip
79265-8765BABO SENSITIVE BABY ALL NATURAL HEALING (SKIN PROTECTANT) OINTMENT [BABO BOTANICALS, INC.]8Legacy NDC, 2 package rows20241215_b3e55f57-3d9d-2a0e-e053-2995a90a4c58.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-876579265-8765-1, 79265-8765-0
79265-856579265-8565-1, 79265-8565-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
OLIVE OIL6UYK2W1W1EIACT
PUERARIA MONTANA VAR. LOBATA ROOTPET93F4I3CIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
EUCALYPTUS OIL2R04ONI662IACT
CHAMOMILEFGL3685T2XIACT
WHITE WAX7G1J5DA97FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SUNFLOWER OIL3W1JG795YIIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
ROSEMARYIJ67X351P9IACT
ROSEMARY OIL8LGU7VM393IACT
OATMEAL8PI54V663YACTIB
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
EUCALYPTUS OIL2R04ONI662IACT
CHAMOMILEFGL3685T2XIACT
WHITE WAX7G1J5DA97FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SUNFLOWER OIL3W1JG795YIIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
ROSEMARY OIL8LGU7VM393IACT
ROSEMARYIJ67X351P9IACT
OATMEAL8PI54V663YACTIB
OLIVE OIL6UYK2W1W1EIACT
LEVOMENOL24WE03BX2TIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
PUERARIA MONTANA VAR. LOBATA ROOTPET93F4I3CIACT

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
291a6b5a-f18b-416c-e063-6294a90a090cb3e55f57-3d9d-2a0e-e053-2995a90a4c582024-12-12WarningsExact identifier
spl id: 291a6b5a-f18b-416c-e063-6294a90a090c
spl set id: b3e55f57-3d9d-2a0e-e053-2995a90a4c58

Reported adverse events (FAERS/openFDA)#

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