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| Product NDC Code | 84710-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Roycederm tea tree therapeutic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION/SHAMPOO | ||||
| RxCUI drug identifier | 205023 | ||||
| Application Number | M032 | ||||
| Labeler Name | Guangzhou Meixi Pharmaceuticals Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Salicylic Acid 3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use: Helps relieve itching, flaking, and scaling associated with dandruff infections.
Purpose
Information about the drug product’s indications for use.Purpose: Anti-Dandruff, Anti-Psoriasis, Anti seborrheic dermatitis
Spl product data elements
Usually a list of ingredients in a drug product.RoyceDerm Tea Tree Therapeutic Salicylic acid MENTHYL LACTATE, (-)- COCAMIDOPROPYL BETAINE HYDROXYACETOPHENONE DIPROPYLENE GLYCOL COCO MONOETHANOLAMIDE SALICYLIC ACID SALICYLIC ACID SODIUM CHLORIDE BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) 1,2-HEXANEDIOL TREHALOSE BUTYLENE GLYCOL COCOYL METHYL MONOETHANOLAMINE ALOE VERA LEAF POTASSIUM COCOYL GLYCINATE PEG-12 DIMETHICONE CITRIC ACID MONOHYDRATE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) MENTHA ARVENSIS LEAF OIL EDETATE DISODIUM SODIUM HYDROXIDE PEG-150 DISTEARATE GARDENIA JASMINOIDES FRUIT GINGER WHEAT GERM OIL CENTELLA ASIATICA TRITERPENOIDS SCUTELLARIA BAICALENSIS ROOT POLYGONUM CUSPIDATUM ROOT GLYCYRRHIZA GLABRA GREEN TEA LEAF CHAMOMILE PIROCTONE OLAMINE POLYQUATERNIUM-10 (10000 MPA.S AT 2%) METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL GLYCOL DISTEARATE CETOSTEARYL ALCOHOL MENTHOL, UNSPECIFIED FORM JOJOBA OIL WATER GLYCERIN GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE ROSEMARY
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label RoyceDerm Tea Tree Therapeutic Shampoo
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Visit www.roycederm.com +1 307 461 0958 Customer care: [email protected]
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API