ATOBOS- allantoin cream 
1004LABORATORY

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.

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ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Centella Asiatica Extract, 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, Panthenol, Glyceryl Citrate/Lactate/Linoleate/Oleate, Portulaca Oleracea Extract, Sorbitan Olivate, Caprylyl Glycol, Arginine, Carbomer, Ammonium Acryloyldimethy/VP Copolymer, Caprylhydroxamic Acid, Glycosyl Trehalose, Water, 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, Asiaticoside, Santalum Album (Sandalwood) Oil, Madecassic Acid, Asiatic Acid, Sodium Hyaluronate, Madecassoside

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

Image of carton

ATOBOS 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69739-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.8 mg  in 160 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69739-040-01160 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2015
Labeler - 1004LABORATORY (689512629)
Registrant - 1004LABORATORY (689512629)
Establishment
NameAddressID/FEIBusiness Operations
1004LABORATORY689512629manufacture(69739-040)

Revised: 4/2015
Document Id: 9af64761-595e-4b34-8806-d186dc32c329
Set id: 60cb3b19-0611-4679-9ccc-0eb40aa9b6b3
Version: 1
Effective Time: 20150427
 
1004LABORATORY