Denorex Extra Strength

Dosage form: shampoo
Ingredients: SALICYLIC ACID 0.03g in 1mL
Labeler: Ultimark Products LLC
NDC Code: 51545-210

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Denorex Extra Strength

Drug Facts

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 20º-25º C (68º – 77º 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)

DENOREX EXTRA STRENGTH 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51545-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.03 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
PROPYLENE GLYCOL 
GLYCOL DISTEARATE 
MENTHOL 
COCAMIDOPROPYL BETAINE 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
SODIUM CITRATE 
FD&C YELLOW NO. 6 
D&C YELLOW NO. 10 
D&C RED NO. 33 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:51545-210-12296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H11/01/2009
Labeler - Ultimark Products LLC (964734078)

Revised: 03/2013
 
Ultimark Products LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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