NIZORAL A-D- ketoconazole shampoo

Nizoral by

Drug Labeling and Warnings

Nizoral by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

NIZORAL   A-D
ketoconazole shampoo

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

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 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
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	04/01/1999
1		125 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50580-895-07	1 in 1 CARTON	04/01/1999
2		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 50580-895-14	1 in 1 CARTON	04/01/1999
3		125 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 50580-895-15	10 in 1 CARTON	04/01/1999
4		6 mL in 1 PACKET; Type 0: Not a Combination Product

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

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)