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 Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

DENOREX EXTRA STRENGTH 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0059
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: 0395-0059-10	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 - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-0059) , analysis(0395-0059) , pack(0395-0059) , label(0395-0059)