Label: ATOBOS- allantoin lotion
- NDC Code(s): 69739-030-01
- 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 April 24, 2015
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- ACTIVE INGREDIENT
Inactive Ingredients: Centella Asiatica Extract, 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
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.
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69739-030 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 Butylene Glycol (UNII: 3XUS85K0RA) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69739-030-01 160 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 03/01/2015 Labeler - 1004LABORATORY (689512629) Registrant - 1004LABORATORY (689512629) Establishment Name Address ID/FEI Business Operations 1004LABORATORY 689512629 manufacture(69739-030)