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.

----------

Mountain Falls 311

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 sulate, 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, red 33

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Pyrithione Zinc Dandruff Shampoo & Conditioner Old Spice Men 2 in 1

Adverse Reactions

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.

311.007/311AL

principal display panel

mountain

falls

*Compare to Head

& Shoulders

helps

prevent

flakes

leaves hair

clean and

manageable

+

conditioner

pH

balanced

formula

2 in 1

dandruff

shampoo

with pyrithione zinc

smooth spice

23.7 FL OZ (700 mL)

image description

2 IN 1 DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-311-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2005
2NDC:11344-311-2188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2005
3NDC:11344-311-391000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2005
4NDC:11344-311-35700 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/23/2005
Labeler - Vi-Jon (150931459)
Registrant - Vi-Jon (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(11344-311)

Revised: 7/2020
Document Id: cb76e112-c01b-4a11-9769-04badd21e2a3
Set id: 608d86b3-ffd0-4f54-a5cb-2c9517fa972d
Version: 5
Effective Time: 20200723
 
Vi-Jon