Nizoral Scalp Itch Relief Shampoo
FDA Label NDC 55505-222

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Nizoral Scalp Itch Relief (NDC 55505-222). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredientPurpose
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.

Otc - 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)

Otc - 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.

Nizoral Scalp Itch Relief Carton (Carton)

Nizoral Scalp Itch Relief Carton (Carton)

* Please review the disclaimer below.