DENOREX EXTRA STRENGTH- salicylic acid shampoo 
Neoteric Cosmetics, Inc.

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 with Conditioner

DRUG FACTS

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

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 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)

DENOREX EXTRA STRENGTH 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-059
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.03 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
MENTHOL (UNII: L7T10EIP3A)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62673-059-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H06/17/2019
Labeler - Neoteric Cosmetics, Inc. (790615181)

Revised: 6/2019
Document Id: d38260e2-4826-4269-ae07-496b396607fa
Set id: 21d234ff-f379-4bcd-9ba0-90f27c6d3a69
Version: 1
Effective Time: 20190617
 
Neoteric Cosmetics, Inc.