Nizoral Eczema Relief Cream
FDA Label NDC 55505-223

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 Eczema Relief Cream (NDC 55505-223). 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, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredientPurpose
Colloidal oatmeal 2.0%Skin protectant

Uses

  • temporarily protects and helps relieve minor skin irritation and itching due to:
    • eczema
    • rashes

Warnings

Warnings
For external use only

When Using This Product

  • avoid contact with the eyes

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

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

  • apply to affected areas of skin as needed

Other Information

  • store product at 20-25°C (68-77°F)
  • for mild to moderate eczema or as directed by a doctor
  • keep carton for full product information.

Inactive Ingredients

allantoin, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, benzyl alcohol, butyrospermum parkii(shea) butter, cetearyl alcohol, chlorphenesin, cyclopentasiloxane, dimethicone, disodium EDTA, ethylhexyl isononanoate, glycerin, glyceryl stearate, hydrogenated polydecene, isododecane, isosorbide dicaprylate, laureth-4, laureth-23, panthenol, PEG-100 stearate, PEG-7 trimethylolpropane coconut ether, petrolatum, tocopheryl acetate, water

Otc - Questions

Questions or comments?
1-800-824-4894

Principal Display Panel

New

Nizoral®

Eczema
Relief Cream

COLLOIDAL OATMEAL 2%
SKIN PROTECTANT

For Eczema Prone Skin

RELIEVES
Dry, Itchy Irritated Skin

SOOTHES & HYDRATES
with 7 Moisturizers

PROECTS
Skin from Itching
& Irritation

HELPS STRENGTHEN
Skin Moisture Barrier

Free of Fragrance,
Steroids & Parabens

Net wt 4 oz (113 g)

Nizoral® Eczema Relief Cream
contains maximum strength medicine
(2% Colloidal Oatmeal) to relieve dry,
itchy and irritated eczema prone skin.
The special pH optimized formula
soothes and hydrates with a unique
blend of 7 moisturizers — plus it's free
of steroids, fragrances and parabens.

Specially 
formulated with:

√ Shea Butter
√ Vitamin B5
√ Vitamin E

Free of:

√ Steroids
√ Fragrances
√ Parabens

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

1.800.824.4894

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

© 2023 KRAMER
LABORATORIES, INC.

0723

Carton Label (Carton)

Carton Label (Carton)

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