Balmers Cooling Zone 31

Manufacturer: Tae Eul Bi Co., Ltd.
Effective date: 2015-07-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:43:07

Label at a glance#

ProductBalmers Cooling Zone 31

Active ingredientPYRITHIONE ZINC

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

zinc pyrithione

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

scalp protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out or reach of the children

INDICATIONS & USAGE SECTION

-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 SECTION

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 SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69927-001-01	2020-01-31	C162847	48780-1	9d75b9d0-1af8-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69927-001-01	Balmers Cooling Zone 31	500 mL in 1 BOTTLE	SHAMPOO	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69927-001	BALMERS COOLING ZONE 31 (PYRITHIONE ZINC) SHAMPOO [TAE EUL BI CO., LTD.]	1	Legacy NDC, 1 package rows	20150720_d3a185a0-3010-4fe3-a113-ddd7cd46d542.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	1
BIOTIN	INACTIVE INGREDIENT	6SO6U10H04	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Balmers Cooling Zone 31
PYRITHIONE ZINC
WATER
BIOTIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69927-001	69927-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PYRITHIONE ZINC	R953O2RHZ5	ACTIB
WATER	059QF0KO0R	IACT
BIOTIN	6SO6U10H04	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
48173f3e-8435-4f75-9f9c-649192633cad			d3a185a0-3010-4fe3-a113-ddd7cd46d542	2015-07-20	Warnings	Exact identifier spl id: 48173f3e-8435-4f75-9f9c-649192633cad spl set id: d3a185a0-3010-4fe3-a113-ddd7cd46d542

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.