Package Insert and Label Information: Pert Plus Dandruff Dismissed

By Innovative Brands, LLC | Last revised: 1 December 2007

PERT PLUS DANDRUFF DISMISSED- pyrithione zinc shampoo, suspension
Innovative Brands, LLC

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.

Pert Plus Dandruff Dismissed Shampoo plus Conditioner
with tea tree oil and wild mint
for dandruff control
MM1

(click image for full-size original)

Active Ingredient

Zinc Pyrithione 0.45%

Purpose and Uses

Purpose

Anti-Dandruff

Uses

Controls the symptoms of dandruff

Warnings

For external use only

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

for best results, use daily or as directed by a doctor. Massage into wet hair, lather and rinse. Repeat if desired.

Inactive Ingredients

Water, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Glycol Distearate, Dimethicone, Fragrance, Melaleuca Alternifolia (tea tree) leaf oil, Carthamus Tinctorius (safflower) seed oil, Mentha Arvensis (wild mint) leaf extract, Cetyl Alcohol, Cocamide MEA, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Hydrogenated Polydecene, Sodium Citrate, Sodium Benzoate, Polyquaternium 10, PEG 7M, Trimethylolpropane Tricaprylate Tricaprate, Citric Acid, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Ammonium Xylenesulfonate, D and C Yellow No. 10, FD and C Blue No. 1.

Questions?

1-800-436-7378 or visit us at www.pertplus.com

Made in Canada

Distributed by Innovative Brands, LLC under license from Procter and Gamble.

Phoenix, AZ 85050

2009

PERT PLUS DANDRUFF DISMISSED
shampoo plus conditioner shampoo, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41595-5506
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (PYRITHIONE ZINC)	PYRITHIONE ZINC	0.45 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Ammonium lauryl sulfate
Glycol stearate
Dimethicone
Cetyl Alcohol
Sodium Citrate
Sodium Benzoate
Polyethylene Glycol 7000
Benzyl Alcohol
Sodium Chloride
Citric Acid
Methylisothiazolinone
FD&C BLUE NO. 1
D&C Yellow No. 10
TEA TREE OIL
SAFFLOWER OIL
MINT

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41595-5506-3	400 mL in 1 BOTTLE	None
2	NDC:41595-5506-4	500 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358	12/01/2007

Labeler — Innovative Brands, LLC (786808134)

Registrant — Innovative Brands, LLC (786808134)

Establishment
Name	Address	ID/FEI	Operations
Body Blue 2006 Inc		243094112	manufacture

Revised: 12/2007 Innovative Brands, LLC