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Package Insert and Label Information: Everyday Clean Dandruff

By Geiss, Destin + Dunn, Inc. | Last revised: 1 January 2012

EVERYDAY CLEAN DANDRUFF — pyrithione zinc shampoo
Geiss, Destin + Dunn, 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 Care for Great Looking Hair
Helps relieve scalp dryness, itch,
irritation and helps prevent flakes.
Clean Manageable Hair Everyday
•Keeps hair clean and manageable for everyday use
•Gentle and pH balanced for everyday use
-even for permed or color-treated hair
Active ingredient
Pyrithione zinc
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
throughly 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 laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate,glycol distearate, amodimethicone, fragrance, cetyl alcohol,
guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride,
methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, trideceth-12, cetrimonium chloride, citric acid, yellow 10, blue 1, red 4
This product is not manufactured or distributed by
Procter + Gamble, distributor of Head + Shoulders
DISTRIBUTED BY: Geiss, Destin + Dunn, Inc.
385 Highway 74 South
Peachtree city, GA 30269
Good Sense
Dandruff
Shampoo
Everyday Clean
For Normal/Oily Hair
with Pyrithione Zinc
Compare to active ingredients of
Head + Shoulders
14.2 FL OZ(420 mL)
image of principal display panel
(click image for full-size original)
EVERYDAY CLEAN DANDRUFF pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75981-153
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 kg in 100 L
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURETH SULFATE
SODIUM LAURYL SULFATE
ZINC CARBONATE
GLYCOL DISTEARATE
CETYL ALCOHOL
MAGNESIUM SULFATE
SODIUM BENZOATE
MAGNESIUM CARBONATE HYDROXIDE
BENZYL ALCOHOL
SODIUM CHLORIDE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
SODIUM XYLENESULFONATE
TRIDECETH-12
CETRIMONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75981-153-15 .420 L in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 07/15/1994
Labeler — Geiss, Destin + Dunn, Inc. (076059836)
Registrant — Vi-Jon, Inc (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, Inc 790752542 manufacture

Revised: 01/2012 Geiss, Destin + Dunn, Inc.