ROYCEDERM SEBORRHEIC DERMATITIS AND PSORIASIS SHAMPOO.- salicylic acid 3% shampoo

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid USP

PURPOSE

Seborrheic dermatitis and psoriasis

DOSAGE & ADMINISTRATION

Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness, and irritation associated with psoriasis and seborrheic dermatitis.

WARNINGS

For external use only.

condition covers a large area of the body.

Avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use as directed

Ask a health professional before use.

In case of accidental ingestion, seek medicaladvice immediately or contact a Poison Control Center right away. (1-800-222-1222)

INDICATIONS & USAGE

• Apply shampoo & massage into the scalp.
• Leave in hair for 3-5 minutes to allow maximum absorption.
• Rinse and repeat as needed.
• Use daily for best results.
• Do not use it on children under 12 years of age unless directed by a doctor.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight

INACTIVE INGREDIENT

Water, Disodium EDTA, Citric acid, SodiumCitrate, Plantapon L61l, ChembetaineCAD, Lamesoft PO65, Glycerin, Zemea Propanediol, Chlorhexidine gluconate,Sodium Benzoate, Dex Panthenol,Polyquaternium-44, Calendula extract,Chamomile extract

QUESTIONS

Visit www.roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM SEBORRHEIC DERMATITIS AND PSORIASIS SHAMPOO. 
salicylic acid 3% shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	7.5 g  in 250 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
CITRIC ACID (UNII: 2968PHW8QP)
GLYCERYL OLEATE (UNII: 4PC054V79P)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURDIMONIUMHYDROXYPROPYL COCOGLUCOSIDES CHLORIDE (UNII: 0O6Q9B860I)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPANEDIOL (UNII: 5965N8W85T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-44 (200000 MW) (UNII: TTD9VOM83O)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-020-01	250 g in 1 CARTON; Type 0: Not a Combination Product	04/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	04/15/2026

Labeler - RoyceDerm LLC (130329531)