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Balmers Cooling Zone 31

Medically reviewed on July 20, 2017

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 1.05g in 100mL
Labeler: Tae Eul Bi Co., Ltd.
NDC Code: 69927-001

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.

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


BALMERS COOLING ZONE 31 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69927-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BIOTIN 
Packaging
#Item CodePackage Description
1NDC:69927-001-01500 mL in 1 BOTTLE
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/FEIOperations
Tae Eul Bi Co., Ltd.689515416manufacture(69927-001)

 
Tae Eul Bi Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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