Denorex Extra Strength
FDA Label NDC 0395-0059

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Denorex Extra Strength (NDC 0395-0059). 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 if you have, when using this product, stop use and ask a doctor if, keep out of 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%

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 the body.

When Using This Product

avoid contact with the eyes. If contact occurs, rinse eyes 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 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

Other Information

Store at 20°-25° C (68° – 77° F)

Inactive Ingredients

cocamidopropyl betaine, D&C Red No. 33, D&C Yellow No. 10, dimethicone PEG-8 meadowfoamate, FD&C Blue No. 1, FD&C Yellow No. 6, fragrance, glycol distearate, menthol, panthenol, polyquaternium-10, PPG-2 hydroxyethyl cocamide, propylene glycol, sodium C14-C16 olefin sulfonate, sodium citrate, vitamin E acetate, water

Questions?

1-800-220-0151

www.denorex.net

Principal Display Panel

EXTRA STRENGTH DENOREX
3 % Salicylic Acid
DANDRUFF Control
SHAMPOO +
CONDITIONER
10 FL OZ (296 mL)

Extra Strength Denorex3 % Salicylic Aciddandruff Controlshampoo +conditioner10 Fl Oz (296 mL) (Denorex Extra Strength 01)

Extra Strength Denorex3 % Salicylic Aciddandruff Controlshampoo +conditioner10 Fl Oz (296 mL) (Denorex Extra Strength 01)

* Please review the disclaimer below.