Label: SOLEP PREMIER HI GRO- panthenol, zinc pyrithione, salicylic acid shampoo
- NDC Code(s): 81077-010-01, 81077-010-02
- Packager: Kobizstar Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
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INACTIVE INGREDIENTS
Water, Potassium Cocoyl Glycinate, Lauryl Glucoside, Lauramidopropyl Betaine, Cocamide MIPA, Tetrasodium EDTA, 1,2-Hexanediol, Illicium Verum (Anise) Fruit Extract, Scutellaria Baicalensis Root Extract, Butylene Glycol, Pantolactone, Polyquaternium-10, Menthol, Citric Acid, Coptis Japonica Root Extract, Rhizophora Mangle Callus Culture Extract, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, 1,2-Hexanediol, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Opuntia Coccinellifera Fruit Extract, Schisandra Chinensis Fruit Extract, Aronia Arbutifolia Extract, Cordyceps Sinensis Extract, Sparassis Crispa Extract, Dioscorea Japonica Root Extract, Albumen Extract, Hydrolyzed Ginseng Saponins, Saponaria Officinalis Leaf Extract, Hydrolyzed Silk, Hydrolyzed Elastin, Hydrolyzed Keratin, Limonene, Linalool
- PURPOSE
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WARNINGS
1. Consult with a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching when using or after use in direct sunlight. 2. Avoid using on wounded areas. 3. Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight. 4. In case of eye contact, wash it off immediately. 5. It may cause hair loss or discoloration if not washed off with water after use.
- KEEP OUT OF REACH OF CHILDREN
- Use(s)
- Directions
- Other Information
- Questions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOLEP PREMIER HI GRO
panthenol, zinc pyrithione, salicylic acid shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81077-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol 1.50 g in 300 mL PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.90 g in 300 mL Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid 0.60 g in 300 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Potassium Cocoyl Glycinate (UNII: WZ70FUF22U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81077-010-02 1 in 1 CARTON 11/01/2020 1 NDC:81077-010-01 300 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/01/2020 Labeler - Kobizstar Co., Ltd. (688506017) Registrant - Kobizstar Co., Ltd. (688506017) Establishment Name Address ID/FEI Business Operations Ester Co., Ltd. 688425766 manufacture(81077-010)
