FDA.reportPublic FDA data

ATOBOS CENTELLA BABY

Manufacturer
1004LABORATORY
Effective date
2015-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:28

Label at a glance#

ProductATOBOS CENTELLA BABY
Active ingredientAllantoin
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Centella Asiatica Extract(70%), Butylene Glycol, Glycerin, Caprylic/ Capric Triglyceride, Butylene glycol Dicaprylate/Dicaprate, Cetyl Alcohol, Squalane, Stearyl Alcohol, Trehalose, Betaine, Panthenol, Glycosyl Trehalose, Hydrogenated Starch Hydrolysate, Dipotassium Glycyrrhizate, Cetearyl Olivate, Sorbitan Olivate, Sorbitan Stearate, Glyceryl Citrate/Lactate/Linoleate/Oleate, Beeswax, Butyrospermum Parkii (Shea) Butter, Macadamia Integrifolia Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Ceramide 3, Arginine, Ammonium Acryloyldimethy/VP Copolymer, Carbomer, Caprylyl Glycol, Caprylhydroxamic Acid, Citrus Aurantium Dulcis (Orange) Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Pelargonium Graveolens Flower Oil, Lavandula Hybrida Oil, Santalum Album (Sandalwood) Oil, Beta-Glucan, Portulaca Oleracea Extract, Sodium Hyaluronate, Water, Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Rhodiola Rosea Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosa Damascena Flower Extract, Taraxacum Officinale (Dandelion) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Artemisia Annua Extract, Calendula Officinalis Flower Extract, Symphytum Officinale Leaf Extract, Helichrysum Arenarium Flower Extract, Azadirachta Indica Leaf Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions. A. Close the lid after use. B. Do not store in high- temperature or low- temperature and keep away from direct sunlight. 4. Wash off the product if it gets in the eye.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: After washing the face & body, dispense an appropriate amount into your palm, and evenly apply to the entire face and body.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69739-080-012020-01-31C16284748780-19d75b9d0-79d2-f424-e053-dadaa90a57ce24cc4e1e-e7a1-435e-b487-07df6013dfb2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69739-080-01ATOBOS CENTELLA BABY160 mL in 1 CARTONLOTION1601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69739-080ATOBOS CENTELLA BABY (ALLANTOIN) LOTION [1004LABORATORY]1Legacy NDC, 1 package rows20150902_24cc4e1e-e7a1-435e-b487-07df6013dfb2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AllantoinACTIVE INGREDIENT344S277G0Z1
ALLANTOINACTIVE MOIETY344S277G0Z1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1U1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69739-08069739-080-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
CENTELLA ASIATICA7M867G6T1UIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
82da8324-5c14-415d-a85b-81c1ed4bf8a024cc4e1e-e7a1-435e-b487-07df6013dfb22015-08-31WarningsExact identifier
spl id: 82da8324-5c14-415d-a85b-81c1ed4bf8a0
spl set id: 24cc4e1e-e7a1-435e-b487-07df6013dfb2

Reported adverse events (FAERS/openFDA)#

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