Label: SOLEP PREMIER HI GRO AMPOULE PACK- panthenol, menthol, salicylic acid liquid
- NDC Code(s): 81077-030-01, 81077-030-02
- 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.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
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INACTIVE INGREDIENTS
Water, Alcohol, Agave Tequilana Leaf Extract, Opuntia Ficus-Indica Stem Extract, Adenium Obesum Leaf Cell Extract, Myrothamnus Flabellifolia Leaf/Stem Extract, Trehalose, Biotin, Tocopheryl Acetate, Thiamin HCL, Cyanocobalamin, Riboflavin, Pyridoxine, Folic acid, Menadione, Bioflavonoids, Ascorbic Acid, Butylene Glycol, 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, Glycereth-25 PCA Isostearate, Triethanolamine, Carbomer, Pantolactone, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Hydroxyethylcellulose, Chlorphenesin, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, PVP, Hydrogenated Lecithin, Squalane, Ceramide NP , Dipotassium Glycyrrhizate, Allantoin, Guaiazulene, Portulaca Oleracea Extract, Centella Asiatica Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Limonene, Linalool, Coptis Japonica Root Extract
- 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. People who have had allergic symptoms should consult a doctor or pharmacist before use. 6. Do not use for children under 3 years of age. 7. people with hypersensitivity to salicylic acid, diabetes, or blood circulation disorders, renal failure, infection, redness etc., people with during menstruation, during pregnancy, or suspected to be pregnant should avoid using it as there is possibility that the current symptoms of skin or body becoming irritable or abnormal skin reactions(edema, inflammation, etc.) may worsen 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 AMPOULE PACK
panthenol, menthol, salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81077-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol 0.20 g in 40 mL Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 0.11 g in 40 mL Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid 0.10 g in 40 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81077-030-02 1 in 1 CARTON 11/01/2020 1 NDC:81077-030-01 40 mL in 1 TUBE; 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(81077-030)
