PYRITHIONE ZINC- pyrithione zinc shampoo 
OLD EAST MAIN CO.

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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Tea Tree 2 in 1 Dandruff Shampoo and Conditioner
470AB/470.000

claims

Multiple Benefit formula to help:

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, Mentha piperita (peppermint) oil, Mentha arvensis leaf oil, Melaleuca alternifolia (tea tree) leaf oil, citric acid, methylchloroisothiazolinone, methylisothiazolinone, hydroxycitronellal, linalool, blue 1, yellow 5

Disclaimer

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders® Tea Tree Oil 2in1 Dandruff Shampoo + Conditioner.

Adverse Reactions

100% Satisfaction

Guaranteed!

(888)309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal display panel

STUDIO

SELECTION

TEA TREE

DANDRUFF SHAMPOO + CONDITIONER

PYRITHIONE ZINC 1%

Compare to Head & Shoulders® Tea Tree Oil 2 in 1 Dandruff Shampoo & Conditioner*

Cooling relief from scalp itch

Paraben free

2in1

Paraben + Phthalate Free

12.5 FL OZ (370 mL)

image description

PYRITHIONE ZINC 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-470
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)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75712-470-32370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/25/2023
Labeler - OLD EAST MAIN CO. (006946172)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(75712-470)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(75712-470)

Revised: 9/2023
Document Id: d9f4fcf5-4fc6-4231-942c-23759bf8e589
Set id: f17154e2-1bcf-43f9-b201-e84d374a0591
Version: 1
Effective Time: 20230925
 
OLD EAST MAIN CO.