DENOREX EXTRA STRENGTH- salicylic acid shampoo

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Ultimark Products LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis - 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
Authorization status:
OTC monograph final
Authorization number:
51545-210-12

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51545-210

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

0 .0 3 g in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)

Ultimark Products LLC

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

MENTHO L (UNII: L7T10 EIP3A)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51545-210 -12

29 6 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 9 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 9 /0 9 /20 19

Labeler -

Ultimark Products LLC (964734078)

Registrant -

Humco Holding Group, Inc. (825672884)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Humco Ho lding Gro up, Inc

8 256 728 8 4

manufacture(51545-210 ) , analysis(51545-210 ) , pack(51545-210 ) , label(51545-210 )

Revised: 9/2019

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