Label: ATOBOS WASH- allantoin shampoo
- NDC Code(s): 69739-050-01
- 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 27, 2015
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- ACTIVE INGREDIENT
Inactive Ingredients: Centella Asiatica Extract, Water, Glycerin, Lauryl Glucoside, TEA-Cocoyl Glutamate, Potassium Cocoyl Glycinate, Diglycerin, Glyceryl Caprylate, Dehydroxanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Oil, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Reticulata (Tangerine) Leaf Oil, Pelargonium Graveolens Flower Oil, Lavandula Hybrida Oil, Santalum Album (Sandalwood) Oil, Portulaca Oleracea Extract, Beta-Glucan, Trehalose, Macadamia Integrifolia Seed Oil, Butyrospermum Parkii (Shea) Butter, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Madecassoside, Sodium Hyaluronate, Asiaticoside, Madecassic Acid, Asiatic Acid, Ceramide 3
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
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69739-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 1.5 mg in 300 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69739-050-01 300 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(69739-050)