Label: ATOBOS BABY AQUA SOOTHING- allantoin gel
- NDC Code(s): 69739-070-01
- Packager: 1004LABORATORY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated July 24, 2015
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- ACTIVE 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
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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ATOBOS BABY AQUA SOOTHING
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69739-070 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) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69739-070-01 160 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(69739-070)