DENOREX EXTRA STRENGTH- salicylic acid shampoo
Ultimark Products LLC

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51545-210
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51545-210-12	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2019	06/22/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M032	09/09/2019	06/22/2022

Labeler - Ultimark Products LLC (964734078)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc		825672884	manufacture(51545-210) , analysis(51545-210) , pack(51545-210) , label(51545-210)

Revised: 6/2022

Document Id: e20d9f25-b98a-9a7a-e053-2995a90a7187

Set id: 2b66b58a-9b46-4a20-848e-18a8e090919d

Version: 7

Effective Time: 20220622

Ultimark Products LLC