REPIEL SMART FOOT PEELING PERFECT CARE- salicylic acid patch

REPIEL SMART FOOT PEELING PERFECT CARE by

Drug Labeling and Warnings

REPIEL SMART FOOT PEELING PERFECT CARE by is a Otc medication manufactured, distributed, or labeled by THE COSRISE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid 0.1%

INACTIVE INGREDIENT

Inactive Ingredients: Alcohol Denat, Water, Propylene Glycol, Lactic Acid, Isopropyl Alcohol, Urea, Glycolic Acid, hydroxypropylcellulose, Betaine, Potassium Hydroxide, PEG-60 Hydrogenated Castor Oil, Menthol, Salicylic Acid, Fragrance, Disodium EDTA, Calendula Officinalis Flower Extract, Viola Tricolor Extract, Chrysanthemum Morifolium Flower Extract, Prunus Serrulata Flower Extract, Camellia Sinensis Leaf Extract, Melissa officinalis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus linearis Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Coix Lacryma-Jobi Ma-yuen Seed Extract, Glycine Soja (Soybean) Seed Extract, Triticum Vulgare (Wheat) Seed Extract, Oryza Sativa (Rice) Extract, Phaseolus Radiatus Seed Extract, Zea Mays (Corn) Kernel Extract, Cnidium Officinale Root Extract, Coptis Japonica Root Extract, Ganoderma Lucidum (Mushroom) Extract, Phellinus Linteus Extract, Rheum Palmatum Root Extract, Laminaria Japonica Extract, Chlorella Vulgaris Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Limon (Lemon) Fruit Extract

PURPOSE

Purpose: Foot exfoliating mask

WARNINGS

Warnings: For external use only. 1. If the following symptoms arise upon use of the cosmetic product, immediately discontinue use and consult a dermatologist, for continued use may aggravate the symptoms. A. Redness, swelling, itchiness, stimulation, or other symptoms B. Occurrence of the above symptoms upon exposure to direct sunlight. 2. Do not use on areas with wounds, eczema, or dermatitis. 3. Caution for treatment and keeping. A. Use immediately upon opening. B. Keep it out of infants of children's reach. C. Do not store in areas with extreme heat or cold, or under direct sunlight. 4. Avoid the eye, nose and mouth area 5. First-time user should test on the skin by applying a small amount to a small area of the skin. This product is exclusively for foot use. 6. Contain Salicylic Acid. Do not use on children under 3 years old due to possible skin irritation. 7. This Product contains highly-concentrated AHA, so a consultation with a dermatologist is required before use. 8. This product contains Propylene Glycol, so people who are sensitive to this substance of have a medical history of an allergic reaction to this substance should be cautious when using this product

KEEP OUT OF REACH OF CHILDREN

Keep it out of infants of children's reach.

INDICATIONS & USAGE

Indications & Usage: Get rid of dull and dead skin on the foot

How to use: 1. Cut the center line of the Foot peeling mask with scissors after washing the foot. 2. Wear the foot peeling masks on both feet and tight the gloves by sticker strap. 3. Take off the socks after one and half hours. 4. wash the feet gently with water. After 4~5 days, the dirty skin starts to peel off. In 10~14 days, all the rough and dirty foot skin is removed. (Recommendable Use Time: 1.5 hour) *The peeling effect may depend on each person’s condition and please keep the recommendable use hour. It may get the skin hurt in case of excess of the recommendable hour.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use once a month.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REPIEL SMART FOOT PEELING PERFECT CARE 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70758-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	0.04 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70758-050-02	10 in 1 CARTON	05/01/2016
1	NDC: 70758-050-01	40 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		05/01/2016

Labeler - THE COSRISE CO.,LTD (689840253)

Registrant - THE COSRISE CO.,LTD (689840253)

Establishment
Name	Address	ID/FEI	Business Operations
THE COSRISE CO.,LTD		689840253	manufacture(70758-050)