Label: SOLEP PREMIER HI GRO TONIC- menthol, panthenol, salicylic acid spray
- NDC Code(s): 81077-020-01, 81077-020-02
- 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
Aloe Barbadensis Leaf Extract, Alcohol, Opuntia Coccinellifera Fruit Extract, Schisandra Chinensis Fruit Extract, Aronia Arbutifolia Extract, Cordyceps Sinensis Extract, Sparassis Crispa Extract, Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Centella Asiatica Extract, Asiaticoside, Asiatic Acid, Madecassic Acid, Madecassoside, Propolis Extract, Hydrolyzed Wheat Protein, Hydrolyzed Corn Protein, Avena Sativa (Oat) Protein Extract, Saccharomyces/Soy Protein Ferment, Hydrolyzed Barley Protein, Hydrolyzed Rice Protein, Hydrolyzed Soymilk Protein, Hydrolyzed Yeast Protein, Hydrolyzed Potato Protein, Hydrolyzed Rice Bran Protein, Hydrolyzed Cottonseed Protein, Hydrolyzed Pea Protein, Hydrolyzed Sweet Almond Protein, Hydrolyzed Vegetable Protein, Glycine Soja (Soybean) Protein, Hydrolyzed Hazelnut Protein, Glycereth-25 PCA Isostearate, Pantolactone, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Chlorphenesin, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Betaine, Raffinose, Inositol, Hyaluronic Acid, Histidine, Glutamine, Glycine, Lysine, Arginine, Cysteine, Sodium Citrate, 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. 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 TONIC
menthol, panthenol, salicylic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81077-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 0.29 g in 100 mL Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol 0.22 g in 100 mL Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid 0.25 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81077-020-02 1 in 1 CARTON 11/01/2020 1 NDC:81077-020-01 100 mL in 1 BOTTLE, SPRAY; 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(81077-020)
