Roycederm Tea Tree Therapeutic
FDA Label NDC 84710-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Meixi Pharmaceuticals Co., Ltd. for the product Roycederm Tea Tree Therapeutic (NDC 84710-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Questions

→ Statement Of Identity

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient: Salicylic Acid 3%

Otc - Purpose

Purpose: Anti-Dandruff, Anti-Psoriasis, Anti seborrheic dermatitis

Indications & Usage

Use: Helps relieve itching, flaking, and scaling associated with dandruff infections.

Warnings

Warnings:

For external use only.

Do not use it on damaged or inflamed scalp.

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

Discontinue use and consult a doctor if condition worsens or does not improve after regular use.

If children under 12 years old, and pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center.

Dosage & Administration

Directions:

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.

Shelf Life: 3 Years

Inactive Ingredient

Inactive Ingredients: 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