DRY SCALP DANDRUFF- pyrithione zinc shampoo

Dry Scalp Dandruff by

Drug Labeling and Warnings

Dry Scalp Dandruff by is a Otc medication manufactured, distributed, or labeled by Fred's Inc, Vi-Jon. 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 oiliness
• Prevent flakes
• Leave hair healthy looking

Active ingredients

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, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders Dry Scalp Care

Adverse reaction

DISTRIBUTED BY: fred's, Inc

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

fred's Promise

Not Happy With This Product?

Just Bring It Back For a Refund?

281.007/281AK

principal display panel

Fred's

Dry Scalp

Dandruff

Shampoo

with almond oil

Pyrithione Zinc

Moisture balancing

For Dry Scalp

Relief

fred's

LAB TESTED

Lab Tested for quality,

Fred Tested for Satisfaction

Compare to

Head & Shoulders

Dry Scalp Care

14.2 FL OZ

(420 mL)

INGREDIENTS AND APPEARANCE

DRY SCALP DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-281
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)
ALMOND OIL (UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-281-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/09/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/09/2009

Labeler - Fred's Inc (005866116)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55315-281)