SIMPLY CLEAN DANDRUFF- pyrithione zinc shampoo

Simply Clean Dandruff by

Drug Labeling and Warnings

Simply Clean Dandruff by is a Otc medication manufactured, distributed, or labeled by Old East Main Co., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

Multiple benefit formula to help:

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

Acitive 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, sodim xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroypropyltrimonium 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 Classic Clean Dandruff Shampoo

Adverse reactions

DISTRIBUTED BY DOLGENCORP, LC

1OO MSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!

(888)309-9030

153.008/153BC

principal display panel

STUDIO

SELECTION

DANDRUFF

SHAMPOO

PYRITHIONE ZINC 1%

Compare to Head & Shoulders

Classic Clean Dandruff Shampoo

For normal

or oily hair

SIMPLY 

CLEAN

helps control dandruff

and leaves hair soft

and manageable

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

SIMPLY CLEAN DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 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: 55910-153-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/1995
2	NDC: 55910-153-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/1995
3	NDC: 55910-153-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/15/1995

Labeler - Dolgencorp, LLC (068331990)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(55910-153)