Label: BALLVIC SEBO- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 70540-020-01 - Packager: INNOGENE CO.,LTD
- 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.
Drug Label Information
Updated March 21, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Sodium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Cocamide DEA, Dimethiconol, Glycol Distearate, Brassica Campestris (Rapeseed) Sterols, Cetearyl Alcohol, SD Alcohol 40-B, Climbazole, Glycerin, Mannitol, Propylene Glycol, Salicylic Acid, Silicone Quaternium-1, TEA-Dodecylbenzenesulfonate, Hydrolyzed Yeast Protein, Menthol, Polyquaternium-10, Ammonium Glycyrrhizate, Citric Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Caffeine, Pyridoxine HCL, Allantoin, Biotin, Disodium EDTA, Guar Hydroxypropyltrimonium Chloride, Niacinamide, Panthenol, Zinc Gluconate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Methylchloroisothiazolinone, Methylisothiazolinone
- PURPOSE
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WARNINGS
Warnings: 1. If the following conditions occur, you must stop using immediately. Continuous use will make the conditions worsen. Consult your dermatologist. a. Red swellings such as erythema, itchiness, or irritations. b. When directly sunlight causes the conditions mentioned above. 2. Do not apply on skin conditions such as wounds, eczema, ordermatitis. 3. Storage and Handling. a. Make sure to close the cap after use. b. Keep out of the reach of children. c. Avoid low temperature, high temperature, or direct sunlight. 4. When in eyes, wash immediately. 5. Not washing thoroughly after shampooing may cause hair loss or change in color. Make sure to wash thoroughly after use.
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BALLVIC SEBO
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70540-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 2.3 g in 230 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70540-020-01 230 g 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 part358H 02/01/2016 Labeler - INNOGENE CO.,LTD (688201056) Registrant - INNOGENE CO.,LTD (688201056) Establishment Name Address ID/FEI Business Operations INNOGENE CO.,LTD 688201056 manufacture(70540-020)
