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

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Nizoral®
A-D KETOCONAZOLE SHAMPOO 1%

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

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)

Principal Display Panel
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 (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
carbomer 1342 (UNII: 809Y72KV36)  
Butylated hydroxytoluene (UNII: 1P9D0Z171K)  
Coco Monoethanolamide (UNII: C80684146D)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
Glycol Distearate (UNII: 13W7MDN21W)  
hydrochloric acid (UNII: QTT17582CB)  
Quaternium-15 (UNII: E40U03LEM0)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Sodium Laureth Sulfate (UNII: BPV390UAP0)  
Edetate Sodium (UNII: MP1J8420LU)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Color BLUE (opaque, pearlescent blue to blue green) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-895-04 1 in 1 CARTON
1 125 mL in 1 BOTTLE
2 NDC:50580-895-07 1 in 1 CARTON
2 200 mL in 1 BOTTLE
3 NDC:50580-895-14 1 in 1 CARTON
3 125 mL in 1 BOTTLE
4 NDC:50580-895-15 10 in 1 CARTON
4 6 mL in 1 PACKET
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
Document Id: c58b8f1c-0481-466a-b660-0c8df63dd74e
Set id: 0ae873af-1307-4cfb-b508-988e08bd8499
Version: 1
Effective Time: 20101122
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc