FOLLIGEN PLUS- pyrithione zinc shampoo
Humajor 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

PYRITHIONE ZINC

WATER, GLYCERIN, MENTHOL

Dandruff improvement

Prevent hairloss

Help hair growth

Scalp sebum reduction

Scalp cleansing

keep out of reach of the children

Apply to wet hair. Work into rich lather and gently massage into scalp and hair. Rinse thoroughly

for external use only

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor. If condition worsens or does not improve after regular use as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep it in airtight container in room temperature(1~30degree C)

Label

FOLLIGEN PLUS
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69244-0002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.008 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69244-0002-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/27/2016	05/04/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	06/27/2016	05/04/2018

Labeler - Humajor Co., Ltd. (689061827)

Registrant - Humajor Co., Ltd. (689061827)

Name	Address	ID/FEI	Business Operations
Establishment
Humajor Co., Ltd.		689061827	manufacture(69244-0002)

Revised: 5/2018

Document Id: 6b65880b-7e75-115c-e053-2a91aa0ab01b

Set id: 2b1b138f-67c0-423d-8aa8-630ff826ee21

Version: 5

Effective Time: 20180504

Humajor Co., Ltd.