NIZORAL A-D- ketoconazole shampoo 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-895
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (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-3 SULFATE (UNII: BPV390UAP0)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
SODIUM COCOYL SARCOSINATE (UNII: 1R9DUY89CZ)  
Product Characteristics
Colorblue (opaque, pearlescent blue to blue green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-895-041 in 1 CARTON04/01/199909/30/2020
1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-895-071 in 1 CARTON04/01/199909/30/2020
2200 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:50580-895-141 in 1 CARTON04/01/199909/30/2020
3125 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:50580-895-1510 in 1 CARTON04/01/199909/30/2020
46 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02031004/01/199909/30/2020
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 9/2021
Document Id: cc90f30c-824b-5b0f-e053-2a95a90ae4da
Set id: 0ae873af-1307-4cfb-b508-988e08bd8499
Version: 5
Effective Time: 20210922
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division