Label: PELO SCALP TONIC SHEET- levomenthol, salicylic acid, dexpanthenol patch

  • 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.

  • ACTIVE INGREDIENT

    Active ingredients: LEVOMENTHOL 0.30%, SALICYLIC ACID 0.25%, DEXPANTHENOL 0.20%

  • 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

    Purpose: Anti hair loss

  • 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

    Keep out of reach of babies and children

  • Uses

    Uses:
    Helps prevent hair loss

  • Directions

    Directions:
    Whenever necessary, apply scalp tonic sheet to the scalp properly, then rub thoroughly using your fingertips to massage.

  • QUESTIONS

    Questions:
    +82-2-983-1257
    Homepage: http://www.drpelo.co.kr

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PELO SCALP TONIC SHEET 
    levomenthol, salicylic acid, dexpanthenol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73099-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.10 g  in 36 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.09 g  in 36 mL
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL0.07 g  in 36 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73099-010-025 in 1 CARTON04/01/2019
    1NDC:73099-010-0136 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2019
    Labeler - Foxtron, Inc (689827776)
    Registrant - Foxtron, Inc (689827776)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enveco Cosmetic Co., Ltd.689061861manufacture(73099-010)