Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID dba59238-6beb-447e-8c4c-e4bc00fd2c20
Route
TOPICAL
Published
Effective Date 2023-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Aloe Dipropylene Glycol Edetate Disodium Anhydrous Glycerin Hyaluronic Acid Menthol, Unspecified Form Peg-12 Dimethicone (300 Cst) Phenoxyethanol Ethylhexylglycerin Polysorbate 80 .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Active ingredient Purpose Hydrocortisone 1.0% Anti-itch liquid


Medication Information

Warnings and Precautions

Warnings

For external use only. Use only as directed

Flammable. Keep away from fire, or flame.

Description

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
Section 50565-1

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

Section 53413-1

Questions? 1-800-824-4894

Section 55105-1
Active ingredient Purpose
Hydrocortisone 1.0% Anti-itch liquid
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

Do Not Use
  • for the treatment of diaper rash. Consult a doctor.
  • If you are allergic to any ingredient in this product
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)

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.

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.


Structured Label Content

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 and Precautions (34071-1)

Warnings

For external use only. Use only as directed

Flammable. Keep away from fire, or flame.

Section 50565-1 (50565-1)

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

Section 53413-1 (53413-1)

Questions? 1-800-824-4894

Section 55105-1 (55105-1)
Active ingredient Purpose
Hydrocortisone 1.0% Anti-itch liquid
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

Do Not Use (Do not use)
  • for the treatment of diaper rash. Consult a doctor.
  • If you are allergic to any ingredient in this product
Other Information (Other information)
  • store product at 20-25°C (68-77°F)
  • keep carton for full product information.
Inactive Ingredients (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)

Principal Display Panel (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.

When Using 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 (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.


Advanced Ingredient Data


Raw Label Data

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