Denorex Extra Strength Shampoo
FDA Label NDC 62673-059

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neoteric Cosmetics, Inc. for the product Denorex Extra Strength (NDC 62673-059). 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 active ingredients, purpose, uses, warnings, ask a doctor before use, when using this product, stop use and ask a doctor, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Salicylic acid 3%

(To the left)

Purpose

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Uses

Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis. Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis

Warnings

For external use only.

Ask A Doctor Before Use

If you have a condition that covers a large area of body.

When Using This Product

Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor

If condition worsens or does not improve after regular use of this product as directed.

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well. Apply to wet hair. Gently massage into hair and scalp to work up a lather. Rinse thoroughly and repeat. For best results, use at least twice weekly or as directed by a doctor.

Storage

Store at 68-77o F (20-25o C)

Inactive Ingredients

Sodium C14-C16 Olefin Sulfonate, Water, PPG-2 Hydroxyethyl Cocamide, Cocamidopropyl Betaine, Glycol Distearate, Propylene Glycol, Menthol, Polyquaternium-10, Panthenol (Provitamin B5),

Fragrance, Vitamin E Acetate, Dimethicone, PEG-8 Meadowfoamate, Sodium Citrate, FD&C Yellow No. 6,

D&C Yellow No. 10, D&C Red No. 33, FD&C Blue No. 1

LEFT PANEL

  • GENTLE ENOUGH FOR REGULAR USE
  • CONDITIONS + MOISTURIZES
  • VITAMIN ENRICHED
  • STARTS WORKING IMMEDIATELY

    • RIGHT PANEL

    QUESTIONS?

    1-800-552-5742

    VISIT US AT

    DENOREX.COM

    Manufactured by

    Neoteric Cosmetics, Inc.

    Denver, CO 80239

    MADE IN THE USA

Principal Display Panel

Denorex

EXTRA STRENGTH

MEDICATED

DANDRUFF SHAMPOO

+ CONDITIONER

HELPS CONTROL DANDRUFF,

SEBORRHEIC DERMATITIS + PSORIASIS

CONTAINS 3% SALICYLIC ACID

RELIEVES SCALP IRRITATION+ ITCHING

CONTROLS FLAKING + SCALP BUILDUP

10 FL OZ. (296 ml)

Principal Display Paneldenorex Extra Strengthmedicateddandruff Shampoo+ Conditionerhelps Control Dandruff,seborrheic Dermatitis + Psoriasiscontains 3% Salicylic Acidrelieves Scalp Irritation+ Itchingcontrols Flaking + Scalp Buildup10 Fl Oz. (296 mL) (Denorex Extra Strength With Conditioner 01)

Principal Display Paneldenorex Extra Strengthmedicateddandruff Shampoo+ Conditionerhelps Control Dandruff,seborrheic Dermatitis + Psoriasiscontains 3% Salicylic Acidrelieves Scalp Irritation+ Itchingcontrols Flaking + Scalp Buildup10 Fl Oz. (296 mL) (Denorex Extra Strength With Conditioner 01)


* Please review the disclaimer below.