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ATOBOS CENTELLA BABY by 1004LABORATORY

Dosage form: cream
Ingredients: Allantoin 0.8mg in 160mL
Labeler: 1004LABORATORY
NDC Code: 69739-090

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Centella Asiatica Extract(64%), Glycerin, Butylene Glycol, Butylene glycol Dicaprylate/Dicaprate, Squalane, Caprylic/Capric Triglyceride, Cetyl Alcohol, Sorbitan Stearate, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Trehalose, Betaine, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Beta-Glucan, Macadamia Integrifolia Seed Oil, Cetearyl Olivate, Glyceryl Citrate/Lactate/Linoleate/ Oleate, Portulaca Oleracea Extract, Sorbitan Olivate, Panthenol, Water, Caprylyl Glycol, Arginine, Carbomer, Ammonium Acryloyldimethy/ VP Copolymer, Caprylhydroxamic Acid, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Glycosyl Trehalose, Citrus Aurantium Dulcis (Orange) Oil, Hydrogenated Starch Hydrolysate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Pelargonium Graveolens Flower Oil, Dipotassium Glycyrrhizate, Ceramide 3, Lavandula Hybrida Oil, Santalum Album (Sandalwood) Oil, Azadirachta Indica Leaf Extract, Olea Europaea (Olive) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Artemisia Annua Extract, Taraxacum Officinale (Dandelion) Leaf Extract, Symphytum Officinale Leaf Extract, Helichrysum Arenarium Flower Extract, Calendula Officinalis Flower Extract, Rhodiola Rosea Root Extract, Rosa Damascena Flower Extract, Pulsatilla Koreana Extract, Zanthoxylum Piperitum Fruit Extract, Usnea Barbata (Lichen) Extract, Sodium Hyaluronate, Asiaticoside, Asiatic Acid, Madecassic Acid, Asiatic Acid

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

ATOBOS CENTELLA BABY 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69739-090
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.8 mg  in 160 mL
Inactive Ingredients
Ingredient NameStrength
Centella Asiatica 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:69739-090-01160 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2015
Labeler - 1004LABORATORY (689512629)
Registrant - 1004LABORATORY (689512629)
Establishment
NameAddressID/FEIOperations
1004LABORATORY689512629manufacture(69739-090)

Revised: 08/2015
 
1004LABORATORY

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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