HEAD REMEDY DANDRUFF - pyrithione zinc shampoo
KPSS, 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.

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KMS CALIFORNIA HEAD REMEDY DANDRUFF SHAMPOO

Active Ingredient

Pyrithione Zinc 1.5%

Purpose

Antidandruff

Uses

Controls the symptoms associated with dandruff.

Warnings:

For external use only

Ask a doctor before use if you have

seborrheic dermatitis that covers a large area of the body.

When using this product

avoid eye contact. 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 OUT OF CHILDREN'S REACH.

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

Directions

Lather. Rinse. Repeat if necessary.

Use twice weekly or as directed by a doctor.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Sodium Cocoyl Gluamate, Citric Acid, Propylene Glycol, Lactic Acid, Panthenol, melissa Officinalis (Balm) Extract, Salvia Officinali (Sage) Extract, Rosmarius Officinalis (Rosemary) Extract, Urtica Dioica (Nettle) Extract, Equisetum Arvense (Horsetail) Extrct, Humulus Lupulus (Hops) Extract, Chamomilla Recutita (Matricaria) Flower Extract, PPG-9, Sodium Chloride, PEG-3 Distearate, Sodium Hydroxide, Hydroxypropyl Guar Hydorxypropyltrimonium Chloride, Quaternium-80, Sodium Naphalenesulfonate, Butylene Glycol, Croscarmellose, Glucose, Sodium Benzoate, Benzoic Acid, DMDM Hydantoin, Fragrance, Blue 1

Controls itchiness and flaking associated with dandruf for a soothed, healthy scalp

Technology Nature

NATURAL INGREDIETNS

rosemary chamomile

KPSS, Inc. Linthicum Heights,

MD 21090, USA

Made in the USA

www.kmscalifornia.com

Head Remedy

HEAD REMEDY DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:25237-3068
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (PYRITHIONE ZINC)	PYRITHIONE ZINC	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
SODIUM COCOYL GLUTAMATE
CITRIC ACID MONOHYDRATE
PROPYLENE GLYCOL
LACTIC ACID
PANTHENOL
MELISSA OFFICINALIS
SAGE
ROSMARINUS OFFICINALIS FLOWER
URTICA DIOICA LEAF
EQUISETUM ARVENSE BRANCH
HOPS
CHAMOMILE
PPG-9
SODIUM CHLORIDE
SODIUM HYDROXIDE
BUTYLENE GLYCOL
DEXTROSE
SODIUM BENZOATE
BENZOIC ACID
DMDM HYDANTOIN
FD&C BLUE NO. 1

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25237-3068-7	750 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	07/15/2011	02/20/2014

Labeler - KPSS, Inc. (808543149)

Revised: 2/2014

Document Id: b1715070-9750-46d1-8c77-769e9c45a235

Set id: 169e9bd7-54cd-4808-a5a3-9774c8d16050

Version: 2

Effective Time: 20140220

KPSS, Inc.