Initial Drug Listing - Roycederm Tea Tree Therapeutic Shampoo

Initial Drug Listing - Roycederm Tea Tree Therapeutic Shampoo
SPL v1
SPL
SPL Set ID 46542754-2256-a23c-e063-6394a90a7795
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 mg)
Inactive Ingredients
Sodium Benzoate Potassium Sorbate Citric Acid Sodium Laureth Sulfate Aloe Barbadensis Leaf Juice Melaleuca Alternifolia (tea Tree) Leaf Oil Panthenol Sodium Chloride Glycerin Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Salicylic Acid 3%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Helps control dandruff
  • Relieves itching, scaling, and flaking associated with dandruff
Dosage and Administration

Apply shampoo, massage into the scalp, and leave on hair for 3-5 minutes to allow maximum absorption. Then rinse thoroughly and repeat as needed. For best results, use at least twice a week or as directed by a doctor.

Description

Salicylic Acid 3%

Section 50565-1

Keep out of reach of Children.

Section 50567-7
  • Do not use it on damaged or inflamed scalp.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3
  • If condition worsens or does not improve after regular use.
  • If children under 12 years old, and pregnant or breast-feeding.
  • If swallowed, get medical help or contact a posion control center.
Section 51727-6

Aqua, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Cocoyl Glycinate, Cocamidopropyl Betaine, Cocamide MEA, Cocamide Methyl MEA, Sodium Chloride, Glycol Distearate, Acrylates Copolymer, Cetearyl Alcohol, Hydroxyacetophenone, 1,2-Hexanediol, Glycerin, Dipropylene Glycol, Bisamino PEG/PPG-41/3 Aminoethyl PG-Propyl Dimethicone, Guar Hydroxypropyltrimonium Chloride, Piroctone Olamine, Polyquaternium-10, PEG-12 Dimethicone, Citric Acid, Polyquaternium-7, Mentholum, Menthyl Lactate, Mentha Haplocalyx Oil, Disodium EDTA, Sodium Hydroxide, Butylene Glycol, Trehalose, PEG-150 Distearate, Gardenia Jasminoides Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Triticum Vulgare (Wheat) Germ Oil, Aloe Barbadensis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract.

Section 51945-4

Section 53413-1

Visit www.roycederm.com

+1 (307) 461 0958

Section 55105-1

Anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis

Section 55106-9

Salicylic Acid 3%


Structured Label Content

Indications and Usage (34067-9)
  • Helps control dandruff
  • Relieves itching, scaling, and flaking associated with dandruff
Dosage and Administration (34068-7)

Apply shampoo, massage into the scalp, and leave on hair for 3-5 minutes to allow maximum absorption. Then rinse thoroughly and repeat as needed. For best results, use at least twice a week or as directed by a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of Children.

Section 50567-7 (50567-7)
  • Do not use it on damaged or inflamed scalp.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)
  • If condition worsens or does not improve after regular use.
  • If children under 12 years old, and pregnant or breast-feeding.
  • If swallowed, get medical help or contact a posion control center.
Section 51727-6 (51727-6)

Aqua, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Cocoyl Glycinate, Cocamidopropyl Betaine, Cocamide MEA, Cocamide Methyl MEA, Sodium Chloride, Glycol Distearate, Acrylates Copolymer, Cetearyl Alcohol, Hydroxyacetophenone, 1,2-Hexanediol, Glycerin, Dipropylene Glycol, Bisamino PEG/PPG-41/3 Aminoethyl PG-Propyl Dimethicone, Guar Hydroxypropyltrimonium Chloride, Piroctone Olamine, Polyquaternium-10, PEG-12 Dimethicone, Citric Acid, Polyquaternium-7, Mentholum, Menthyl Lactate, Mentha Haplocalyx Oil, Disodium EDTA, Sodium Hydroxide, Butylene Glycol, Trehalose, PEG-150 Distearate, Gardenia Jasminoides Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Triticum Vulgare (Wheat) Germ Oil, Aloe Barbadensis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit www.roycederm.com

+1 (307) 461 0958

Section 55105-1 (55105-1)

Anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis

Section 55106-9 (55106-9)

Salicylic Acid 3%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)