DR.FORHAIR FOLLIGEN- 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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69244-0007_Dr.FORHAIR FOLLIGEN

zinc pyrithione 0.288%

Salicylic Acid 0.2%

Water, Disodium Laureth Sulfosuccinate, Lauryl hydroxy sultaine, Cocamide Methyl MEA, Styrene/Acrylates Copolymer, Glycerin, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Propanediol, Fragrance, Sodium Lauroyl Methylaminopropionate, Alcohol, PEG-45 Palm Kernel Glycerides, Panthenol, C12-13 Alkyl Lactate, Polyquaternium-10, Cetrimonium Chloride, Menthol, Cocamidopropyl Betaine, Caprylyl Glycol, Trihydroxystearin, Disodium EDTA, Zinc Chloride, Sodium benzoate, Polyquaternium-7, PEG-6 Caprylic/Capric Glyceride , Ethylhexylglycerin, Sodium Chloride, Citric Acid, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Adenosine, Disodium Phosphate , Niacinamide, Moringa Oleifera Seed Oil, Tocopherol, Biotin, Ceramide NP, Lecithin, Caprylic/Capric Triglyceride, Polysorbate 80, Serenoa Serrulata Fruit Extract, Caffeic Acid, Rhodiola Rosea Root Extract, Dioscorea Japonica Root Extract, Paeonia Lactiflora Root Extract, Zingiber Officinale (Ginger) Root Extract, Sophora Flavescens Extract, 1,2-Hexanediol

Antidandruff

keep out or reach of the children


Helps prevent recurrence of flaking and itching associated with dandruff

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.

Apply to wet hair. Work into a rich lather and gently massage into scalp and hair. Rinse thoroughly with lukewarm water.

package label

DR.FORHAIR FOLLIGEN 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69244-0007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.88 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)  
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM LAUROYL METHYLAMINOPROPIONATE (UNII: 99E3R68Y9B)  
ALCOHOL (UNII: 3K9958V90M)  
PEG-45 PALM KERNEL GLYCERIDES (UNII: UC117W498W)  
PANTHENOL (UNII: WV9CM0O67Z)  
C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69244-0007-21 in 1 CARTON08/06/2019
1NDC:69244-0007-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/06/2019
Labeler - Humajor Co., Ltd. (689061827)
Registrant - Humajor Co., Ltd. (689061827)
Establishment
NameAddressID/FEIBusiness Operations
Cosmocos Co., Ltd689387376manufacture(69244-0007)

Revised: 8/2019
Document Id: 8f8e5c79-2124-c623-e053-2995a90a4194
Set id: f2dcca44-72a4-4e90-92e9-08c3d95e4893
Version: 1
Effective Time: 20190807
 
Humajor Co., Ltd.