FDA.reportPublic FDA data

RoyceDerm Tea Tree Therapeutic

Manufacturer
Guangzhou Meixi Pharmaceuticals Co., Ltd.
Effective date
2024-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:47

Label at a glance#

ProductRoyceDerm Tea Tree Therapeutic
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Salicylic Acid 3%

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

Questions?
Visit www.roycederm.com

+1 307 461 0958

Customer care: service@roycederm.com

STATEMENT OF IDENTITY SECTION

Distributed by:

RoyceDerm LLC

Sheridan, WY 82801

MANUFACTURED BY:

Guangzhou Meixi Pharmaceuticals Co., Ltd.

Floor 4, 1, No.26, Tengda E. Road, Shilou Town, Panyu District, Guangzhou, CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RoyceDerm Tea Tree Therapeutic ShampooRoyceDerm Tea Tree Therapeutic ShampooLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205023salicylic acid 3 % Medicated ShampooPSN1
205023salicylic acid 30 MG/ML Medicated ShampooSCD1
205023salicylic acid 3 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84710-101-01RoyceDerm Tea Tree Therapeutic350 g in 1 BOTTLELOTION/SHAMPOO3501
84710-101-02RoyceDerm Tea Tree Therapeutic1 in 1 BOXLOTION/SHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84710-101ROYCEDERM TEA TREE THERAPEUTIC (SALICYLIC ACID) LOTION/SHAMPOO [GUANGZHOU MEIXI PHARMACEUTICALS CO., LTD.]12 package rows20240921_21d39b25-8cdf-dad6-e063-6394a90a92b0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84710-10184710-101-01, 84710-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
DIPROPYLENE GLYCOLE107L85C40IACT
COCO MONOETHANOLAMIDEC80684146DIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SODIUM CHLORIDE451W47IQ8XIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TREHALOSEB8WCK70T7IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
COCOYL METHYL MONOETHANOLAMINE79G1T427CFIACT
ALOE VERA LEAFZY81Z83H0XIACT
POTASSIUM COCOYL GLYCINATEWZ70FUF22UIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
GARDENIA JASMINOIDES FRUIT7CTH8MD549IACT
GINGERC5529G5JPQIACT
WHEAT GERM OIL14C97E680PIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT
METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE4M7P1JZ2V2IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
GLYCOL DISTEARATE13W7MDN21WIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
JOJOBA OIL724GKU717MIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
21d39b25-8ce0-dad6-e063-6394a90a92b021d39b25-8cdf-dad6-e063-6394a90a92b02024-09-12WarningsExact identifier
spl id: 21d39b25-8ce0-dad6-e063-6394a90a92b0
spl set id: 21d39b25-8cdf-dad6-e063-6394a90a92b0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.