EASTER SCALP 100ML- pyrithione zinc solution

EASTER SCALP by

Drug Labeling and Warnings

EASTER SCALP by is a Otc medication manufactured, distributed, or labeled by WECOSMETICS Co., Opseve KOREA Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Zinc Pyrithione 0.48%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Glycol Distearate,

Geranium Maculatum Oil, Menthol, Propylene Glycol, Salicylic Acid, Polyquaternium-10, Disodium EDTA, Allantoin,

Niacinamide, Panthenol, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sophora Angustifolia Root Extract,

Morus Alba Bark Extract, Cnidium Officinale Root Extract, Acorus Calamus Root Extract, Panax Ginseng Root Extract,

Polygonum Multiflorum Root Extract, Sodium Benzoate, CI 42090, CI 47005

PURPOSE

Purpose:

A hair shampoo healing quickly and confidently scalp trouble arising from contaminated environment, stress etc, helping to easily do a

professional scalp treatment at home.

WARNINGS

Warnings:

1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as redrash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

4. If you don’t clean with water enough after using, as it can be a cause of hair loss or decolorization, clean with water after using.

5. Caution for storage and handling.

1) Close the stopper without fail after using.

2) Keep out of reach of babies and children.

3) Don’t keep at the place of high temperature and low temperature or direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS & USAGE

Indications & Usage:

After soaking hair and scalp enough into tepid water, apply a proper amount of shampoo mainly on the scalp and foam, and then massage

for 1~2 minutes and rinse clearly with water.

Adjust usage, use cycle, time of leaving aline according to the degree of scalp dryness.

DOSAGE & ADMINISTRATION

Dosage & Administration:

Use a suitable amount of shampoo. But, dry scalp adjusts usage and use cycle.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EASTER SCALP  100ML
pyrithione zinc solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69996-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.09 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69996-040-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/01/2018

Labeler - WECOSMETICS Co. (689515001)

Registrant - WECOSMETICS Co. (689515001)

Establishment
Name	Address	ID/FEI	Business Operations
Opseve KOREA Co.,Ltd.		690048629	manufacture(69996-040)