BALMERS COOLING ZONE 31- pyrithione zinc shampoo

Balmers Cooling Zone 31 by

Drug Labeling and Warnings

Balmers Cooling Zone 31 by is a Otc medication manufactured, distributed, or labeled by Tae Eul Bi Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

zinc pyrithione

INACTIVE INGREDIENT

water, nicotinamide, d-panthenol, biotin, l-menthol, etc.

PURPOSE

scalp protectant

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

-Moisten hair and scalp with warm water sufficiently and massage the scalp with 3~5ml.-Apply a proper amount to foam and apply to the hair and scalp sufficiently.-Massage for about 3 minutes and rinse.

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALMERS COOLING ZONE 31 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69927-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BIOTIN (UNII: 6SO6U10H04)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69927-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/20/2015

Labeler - Tae Eul Bi Co., Ltd. (689515416)

Registrant - Tae Eul Bi Co., Ltd. (689515416)

Establishment
Name	Address	ID/FEI	Business Operations
Tae Eul Bi Co., Ltd.		689515416	manufacture(69927-001)