2 IN 1 DANDRUFF- pyrithione zinc shampoo 
Vi-Jon

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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Dandruff Shampoo Clean Apple Scent

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5

adverse reaction

Multiple benefit formula to help:

*This product is not manufactured or distributed by Procter & Gample, distributor of Head and Shoulders Green Apple 2 in 1 Pyrithione Zinc Dandruff Shampoo and Conditioner.

Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA with US and foreign parts.

612.001/612AC

principal display panel

mountain

falls

Compare to Head & shoulders

helps prevent flakes

+ conditioner

paraben free

pH balanced formula

2 in 1 

dandruff shampoo

with pyritione zinc

clean apple

23.7 FL OZ (700 mL)

image description

2 IN 1 DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-612
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-612-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2016
2NDC:11344-612-92399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2016
3NDC:11344-612-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2016
4NDC:11344-612-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2016
5NDC:11344-612-391000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/06/2016
Labeler - Vi-Jon (150931459)
Registrant - Vi-Jon (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(11344-612)

Revised: 6/2019
Document Id: d74b3492-0dcc-4823-b4d8-9b9b3092961b
Set id: 730f198e-e5da-418b-bb43-fbf920369689
Version: 5
Effective Time: 20190617
 
Vi-Jon