DENOREX THERAPEUTIC- coal tar and menthol 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.

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Denorex Therapeutic

Drug Facts

Active Ingredients:

Coal tar solution 9.0% v/v (equivalent to 1.8% coal tar)

Purpose:

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Active Ingredients:

Menthol 1.5%

Purpose:

Controls scalp itch

Uses:

relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
extra relief of itching due to dandruff

Warnings:

For external use only

Do not use:

for prolonged periods without consulting a doctor
this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

Ask a doctor before use if you have

condition covers a large area of the body.

When using this product:

avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
use caution in exposing skin to sunlight after applying. It may increase your tendency to sunburn for up to 24 hours after application.

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 a week or as directed by a doctor

Inactive ingredients

alcohol 7.3%, avocado oil, chloroxylenol, citric acid, dimethicone copolyol, FD&C red #40, fragrance, glycol distearate, hydroxypropyl methylcellulose, lauramide DEA, panthenol (provitamin B5), PEG-30 lanolin, quaternium-80, ricinoleamidopropyl ethyldimonium ethosulfate, TEA lauryl sulfate, vitamin E acetate, water

Questions?

1-800-443-4908 or www.denoraxshampoo.com

WARNING:

This product contains a chemical known to the State of California to cause cancer.

PRINCIPAL DISPLAY PANEL

Den Thera Lbl 032021.jpg.jpg Den Thera IFC 032021.jpg.jpg THERAPEUTIC

Denorex

1.8 % Coal Tar; 1.5 % Menthol

Maximum Itch Relief

DANDRUFF

S HAMPOO +

CONDITIONER

10 FL OZ (296 mL)

THERAPEUTIC
Denorex
1.8 % Coal Tar; 1.5 % Menthol
Maximum Itch Relief
DANDRUFF
SHAMPOO +
CONDITIONER
10 FL OZ (296 mL)

DENOREX THERAPEUTIC
coal tar and menthol shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51545-220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	0.018 g in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.015 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AVOCADO OIL (UNII: 6VNO72PFC1)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
PANTHENOL (UNII: WV9CM0O67Z)
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: V176GWC2SR)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51545-220-12	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	analysis(51545-220) , manufacture(51545-220) , pack(51545-220) , label(51545-220)

Revised: 6/2022

Document Id: e20d9172-b3b5-c000-e053-2a95a90ab620

Set id: ec277a67-ac3d-4cc0-8d97-d87631aca19d

Version: 10

Effective Time: 20220622

Ultimark Products LLC