Initial Drug Listing - Roycederm Tea Tree Therapeutic Shampoo
46542754-2256-a23c-e063-6394a90a7795
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:49.098233 · Updated: 2026-03-14T23:11:40.308391