Label: PELO SCALP TONIC SHEET- levomenthol, salicylic acid, dexpanthenol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 73099-010-01, 73099-010-02 - Packager: Foxtron, Inc
- 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 May 16, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Houttuynia Cordata Extract, Polygonum Multiflorum Root Extract, Acorus Calamus Root Extract, Alcohol, Centella Asiatica Extract, Poly-sorbate 20, Polyoxyethylene Hydrogenated Castor oil, Phenoxyethanol, L-Menthol, Sodium Citrate, Salicylic Acid, Dexpanthenol, Rosmarinus Officinalis(Rosemary) Leaf Oil, Allantoin, Niacinamide, Hydrolyzed Keratin, Hydrolyzed Collagen, Hydrolyzed Silk, Morus Alba Bark Extract, Camellia Sinensis Leaf Extract, Artemisia Vulgaris Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Cnidium Officinale Root Extract, Hyaluronic Acid, Dipotassium Glycyrrhizate, Disodium EDTA - PURPOSE
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WARNINGS
Warnings:
For external use only
1. Be discontinued immediately the use of this product in the following cases, consult your doctor or pharmacist, at the time of consultation, as far as possible : If rash, erythema, itching, swelling, and the like are displayed
2. Avoid contact with eyes. If product gets into the eyes rinse well with water immediately.
3.People who have hypersensitivity to salicylic acid, diabetes, blood circulation disorder, kidney failure, infectious disease, redness, menstruation, pregnancy or who are pregnant may become hypersensitive to skin or body after use(Edema, inflammation, etc.) may occur and current symptoms may worsen, so avoid using.
4. If you have any allergic symptoms, you should consult your doctor or pharmacist before use.
5. Do not use for children under the age of 3.
6. Keep out of reach of babies and children
- Do not store near high heat or flame
- Do not keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.
- Do not put in other containers for prevent abuse and keep quality - KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PELO SCALP TONIC SHEET
levomenthol, salicylic acid, dexpanthenol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73099-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 0.10 g in 36 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.09 g in 36 mL DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL 0.07 g in 36 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73099-010-02 5 in 1 CARTON 04/01/2019 1 NDC:73099-010-01 36 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2019 Labeler - Foxtron, Inc (689827776) Registrant - Foxtron, Inc (689827776) Establishment Name Address ID/FEI Business Operations Enveco Cosmetic Co., Ltd. 689061861 manufacture(73099-010)