Dandruff Shampoo

Dandruff Shampoo

Drug Labeling and Warnings

Drug Details

k">

DANDRUFF- pyrithione zinc shampoo 
Vi-Jon, Inc

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.

----------

Dandruff Shampoo

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, massage 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, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

 claims

Multiple benefit formula to help:

• Fight dry scalp
• Calm itch
• Relieve irritation
• Soothe and reduce redness
• Reduce oiliness
• Prevent flakes
• Leave hair healthy looking

Adverse Reactions Section

*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.

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.

Principal Display Panel

Mountain falls

*Compare to Head & Shoulders

Helps prevent flakes

+ conditioner 

Leaves hair clean and managable

pH balanced formula

2 in 1 Dandruff Shampoo with pyrithione zinc

smooth spice

23.7 FL OZ (700 mL)

principal display panel

Hand Sanitizer with Lavender + Chamomile

8 FL OZ (236 mL)

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-253-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
2	NDC: 11344-253-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
3	NDC: 11344-253-21	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
4	NDC: 11344-253-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/31/2016

Labeler - Vi-Jon, Inc (150931459)

Registrant - Vi-Jon, Inc (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(11344-253)

Revised: 4/2018

Document Id: 04c52a9c-08e6-4e34-b42a-d5f3f9652dd1

34390-5

Set id: 2a196877-c122-447a-abd5-2b18d7921f57

Version: 4

Effective Time: 20180418

 

Vi-Jon, Inc