PELO SCALP TONIC SHEET- levomenthol, salicylic acid, dexpanthenol patch 
Foxtron, Inc

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.

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Pelo Scalp Tonic Sheet

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

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)

Revised: 5/2019
Document Id: 0ab19357-bfaf-4dd6-8134-89fbeddbd21b
Set id: 5971e820-1a83-444a-87a3-2240dd2c26f0
Version: 1
Effective Time: 20190516
 
Foxtron, Inc