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Name:Nizoral A-d
Manufacturer:Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Nizoral® A-D KETOCONAZOLE SHAMPOO 1%

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

  • 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)

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 (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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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