ATOBOS BABY AQUA SOOTHING- allantoin gel 
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, Water, Panthenol, Betaine, Carbomer, Arginine, Caprylyl Glycol, Glyceryl Polyacrylate, Dipotassium Glycyrrhizate, Caprylhydroxamic Acid, 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

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 BABY AQUA SOOTHING 
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69739-070
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
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69739-070-01160 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2015
Labeler - 1004LABORATORY (689512629)
Registrant - 1004LABORATORY (689512629)
Establishment
NameAddressID/FEIBusiness Operations
1004LABORATORY689512629manufacture(69739-070)

Revised: 7/2015
Document Id: e3b51108-c762-4360-b88c-dc6e5464711d
Set id: fa592271-f713-4440-98f0-f22672161f2f
Version: 1
Effective Time: 20150724
 
1004LABORATORY