OTC Medication Information: Nizoral A-D

By McNeil Consumer Healthcare Div. McNeil-PPC, Inc | Last revised: 22 November 2010

NIZORAL A-D- ketoconazole shampoo
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Drug Facts

Active ingredient

Ketoconazole 1%

Purpose

Anti-dandruff shampoo

Uses

controls flaking, scaling and itching associated with dandruff

Warnings

For external use only

Do not use

on scalp that is broken or inflamed
if you are allergic to ingredients in this product

When using this product

avoid contact with eyes
if product gets into eyes, rinse thoroughly with water

Stop use and ask a doctor if

rash appears
condition worsens or does not improve in 2-4 weeks

If pregnant or breast-feeding , ask a doctor before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over	wet hair thoroughly apply shampoo, generously lather, rinse thoroughly. Repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff.
children under 12 years	ask a doctor

Other information

store between 35° and 86°F (2° and 30°C)
protect from light
protect from freezing
see top panel for lot number and expiration date

Inactive ingredients

acrylic acid polymer (carbomer 1342), butylated hydroxytoluene, cocamide MEA, FD&C Blue #1, fragrance, glycol distearate, polyquaternium-7, quaternium-15, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide and/or hydrochloric acid, sodium laureth sulfate, tetrasodium EDTA, water-

Questions or comments?

call 1-800-962-5357

PRINCIPAL DISPLAY PANEL

NON-PRESCRIPTION STRENGTH

NDC 50580-895-04

Nizoral^®
A-D KETOCONAZOLE SHAMPOO 1%

Anti-Dandruff Shampoo

CONTROLS FLAKING,
SCALING AND ITCHING

The Freedom Will Go To Your Head

4 FL OZ (125 mL)

(click image for full-size original)

NIZORAL A-D
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50580-895
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketoconazole (Ketoconazole)	Ketoconazole	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
carbomer 1342
Butylated hydroxytoluene
Coco Monoethanolamide
FD&C Blue NO. 1
Glycol Distearate
hydrochloric acid
Quaternium-15
Sodium Chloride
Sodium Hydroxide
Sodium Laureth Sulfate
Edetate Sodium
Water

Product Characteristics
Color	BLUE (opaque, pearlescent blue to blue green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50580-895-04	1 BOTTLE (BOTTLE) in 1 CARTON	contains a BOTTLE
1		125 mL in 1 BOTTLE	This package is contained within the CARTON (50580-895-04)
2	NDC:50580-895-07	1 BOTTLE (BOTTLE) in 1 CARTON	contains a BOTTLE
2		200 mL in 1 BOTTLE	This package is contained within the CARTON (50580-895-07)
3	NDC:50580-895-14	1 BOTTLE (BOTTLE) in 1 CARTON	contains a BOTTLE
3		125 mL in 1 BOTTLE	This package is contained within the CARTON (50580-895-14)
4	NDC:50580-895-15	10 PACKET (PACKET) in 1 CARTON	contains a PACKET
4		6 mL in 1 PACKET	This package is contained within the CARTON (50580-895-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020310	04/01/1999

Labeler — McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 11/2010 McNeil Consumer Healthcare Div. McNeil-PPC, Inc

OTC Labels

Over the Counter Medications