ATOBOS CENTELLA BABY- allantoin lotion

ATOBOS CENTELLA BABY by

Drug Labeling and Warnings

ATOBOS CENTELLA BABY by is a Otc medication manufactured, distributed, or labeled by 1004LABORATORY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

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

Purpose: Skin Protectant

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

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: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOBOS CENTELLA BABY 
allantoin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69739-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.8 mg  in 160 mL

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA (UNII: 7M867G6T1U)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69739-080-01	160 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2015

Labeler - 1004LABORATORY (689512629)

Registrant - 1004LABORATORY (689512629)

Establishment
Name	Address	ID/FEI	Business Operations
1004LABORATORY		689512629	manufacture(69739-080)