FRESH MINT 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  309

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

• 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.

Directions

• shake well  • for maximum dandruff control, use every time you shampoo • wet hair, message onto scalp, rinse, repeat if desired • for best results use at least twice a week or as directed by a doctor

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, red 33

principal display panel

Dandruff Shampoo
14.2 FL OZ (420 mL)

image description

FRESH MINT DANDRUFF  
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-309-15.402 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
2NDC:11344-309-21.088 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
3NDC:11344-309-35.700 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
4NDC:11344-309-391.0 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/21/2004
Labeler - Vi Jon (150931459)
Registrant - Vi Jon (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon088520668manufacture(11344-309)

Revised: 1/2020
Document Id: e65bc1fb-7376-41d2-bf99-e6d342dbb3cf
Set id: 4a06ee5f-736c-40ce-88eb-86f63e019566
Version: 2
Effective Time: 20200117
 
Vi Jon