PERT PLUS 2 IN 1 SHAMPOO AND CONDITIONER DRY SCALP CARE- pyrithione zinc shampoo, suspension

Pert Plus 2 in 1 Shampoo and Conditioner by

Drug Labeling and Warnings

Pert Plus 2 in 1 Shampoo and Conditioner by is a Otc medication manufactured, distributed, or labeled by Idelle Labs, Ltd, Body Blue 2006 Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Pert Plus 2 in 1 Shampoo & Conditioner Dry Scalp Care
for moisturizing and relieving scalp itch
Great hair should be simple
Use daily: 1. Wet 2. Lather 3. Rinse.
MM1

Active Ingredient

Active Ingredient

Pyrithione Zinc 1.0%

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 and ask a doctor if

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

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 at least twice a week or as directed by a doctor. Gently massage into wet hair, lather and rinse. Repeat if desired.

Inactive Ingredients

Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, dimethicone, cetyl alcohol, cocamide MEA, sodium chloride, fragrance, guar hydroxypropyltrimonium chloride, hydrogenated polydecene, sodium citrate, sodium benzoate, polyquaternium 10, PEG-7M, trimethylolpropane tricaprylate/tricaprate, citric acid, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, ammonium xylene sulfonate, Yellow 10, Blue 1.

Questions or Comments?

1-800-487-7273
www.pertplus.com

Idelle Labs, Ltd. All rights reserved.
Made in Canada. Distributed by Idelle Labs, Ltd., El Paso, TX 79912

PRINCIPAL DISPLAY PANEL

label

INGREDIENTS AND APPEARANCE

PERT PLUS 2 IN 1 SHAMPOO AND CONDITIONER  DRY SCALP CARE
pyrithione zinc shampoo, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41595-6503
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 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41595-6503-1	400 mL in 1 BOTTLE
2	NDC: 41595-6503-2	750 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	06/01/2012

Labeler - Idelle Labs, Ltd (128822926)

Registrant - Idelle Labs, Ltd (128822926)

Establishment
Name	Address	ID/FEI	Business Operations
Body Blue 2006 Inc.		243094112	MANUFACTURE