DENOREX EXTRA STRENGTH- salicylic acid shampoo

Denorex Extra Strength by

Drug Labeling and Warnings

Denorex Extra Strength by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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)

INGREDIENTS AND APPEARANCE

DENOREX EXTRA STRENGTH 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.03 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62673-059-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	06/17/2019

Labeler - Neoteric Cosmetics, Inc. (790615181)