NIZORAL SCALP ITCH RELIEF- hydrocortisone shampoo

Nizoral Scalp Itch Relief by

Drug Labeling and Warnings

Nizoral Scalp Itch Relief by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Hydrocortisone 1.0%: Anti-itch liquid

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
    
  • seborrheic dermatitis

• other uses of this product should be only under the advice and supervision of a doctor

WARNINGS

Warnings
For external use only. Use only as directed

Flammable. Keep away from fire, or flame.

Do not use

• for the treatment of diaper rash. Consult a doctor.
• If you are allergic to any ingredient in this product

When using this product

• avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor.
  

KEEP OUT OF REACH OF CHILDREN

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

Directions

• twist the applicator tip to open.
• if applying after shampooing, towel dry hair before use.
• squeeze bottle gently to avoid excess dripping.
  
• apply solution directly to scalp and massage in.
  
• twist applicator tip tightly after use.
  
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  
• children under 2 years of age: do not use, ask a doctor
  

Other information

• store product at 20-25°C (68-77°F)
• keep carton for full product information.

Inactive ingredients

alcohol denat., aloe barbadensis leaf juice, dipropylene glycol, disodium EDTA, glycerin, hyaluronic acid, menthol, PEG-12 dimethicone, phenoxyethanol and ethylhexylglycerin, polysorbate-80, tocopheryl acetate, water (aqua)

QUESTIONS

Questions? 1-800-824-4894

PRINCIPAL DISPLAY PANEL

Nizoral®

Scalp Itch Relief

HYDROCORTISONE 1%
ANTI-ITCH LIQUID 

RELIEVES SCALP ITCH
from seborrheic dermatitis,
psoriasis & eczema

SOOTHES, CALMS & HYDRATES
plus aloe, menthol & hyaluronic acid

MAXIMUM STRENGTH
anti-itch medicine

fragrance-free greaseless formula

2 fl oz (60mL)

NIZORAL®
Scalp Itch Relief
contains maximum strength
medicine (Hydrocortisone
1%) to relieve scalp itch.
The special medicated
solution helps soothe, calm,
& hydrate an itchy, irritated
scalp; plus it contains
aloe, menthol, vitamin E
& hyaluronic acid. The
tapered bottle tip design
helps easily apply the
medicated solution that's
paraben free, fragrance
free, and greaseless.

Specially 
formulated with:

√ Aloe
√ Menthol
√ Hyaluronic Acid
√ Vitamin E

Before use, read all label information.
If you have a drug reaction, contact a
doctor and report it by calling:
1.800.824.4894

KRAMER
LABORITORIES

Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807 USA

© 2023 KRAMER LABORATORIES, INC.

INGREDIENTS AND APPEARANCE

NIZORAL SCALP ITCH RELIEF 
hydrocortisone shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Aloe (UNII: V5VD430YW9)
Dipropylene Glycol (UNII: E107L85C40)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Glycerin (UNII: PDC6A3C0OX)
Hyaluronic Acid (UNII: S270N0TRQY)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Polysorbate 80 (UNII: 6OZP39ZG8H)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-222-29	1 in 1 CARTON	01/01/2024
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2024

Labeler - Kramer Laboratories (122720675)