DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Inc., Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ro contact a Poison Control Center right away.

Directions

• shake well
• for manimum 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 chloried, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5

SPL UNCLASSIFIED SECTION

Multiple benefit formula to help:

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

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders green apple 2 in 1 Dandruff Shampoo & conditioner

Not 100% satisfied?
Return package and unused product within 30 days to any Family Dollar store for a refund ( with receipt) or exchange.
DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.
10401 MONROE ROAD
MATTHEWS NC 28105

Principal Display Panel

FAMILY DOLLAR 100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Compare to HEAD & SHOULDERS DANDRUFF SHAMPOO*

pyrithione zinc

dandruff shampoo plus conditioner 2 in 1

clean apple

helps relieve scalp dryness, itcing, and light flaking while keeping hair clean, soft, and healthy looking

14.2 FL OZ (420 mL)

612.001/612AC

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-612
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 g  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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-612-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/18/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/18/2012

Labeler - Family Dollar Services, Inc. (024472631)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55319-612)