BALMERS COOLING ZONE 31 - pyrithione zinc shampoo 
Tae Eul Bi Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

zinc pyrithione


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


scalp protectant


keep out or reach of the children


-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.

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


for external use only


package label
BALMERS COOLING ZONE 31 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69927-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BIOTIN (UNII: 6SO6U10H04)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69927-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/20/2015
Labeler - Tae Eul Bi Co., Ltd. (689515416)
Registrant - Tae Eul Bi Co., Ltd. (689515416)
Establishment
NameAddressID/FEIBusiness Operations
Tae Eul Bi Co., Ltd.689515416manufacture(69927-001)

Revised: 7/2015
Document Id: 48173f3e-8435-4f75-9f9c-649192633cad
Set id: d3a185a0-3010-4fe3-a113-ddd7cd46d542
Version: 1
Effective Time: 20150720
 
Tae Eul Bi Co., Ltd.