FDA.reportPublic FDA data

Rosatra Synergy

Manufacturer
PHYTOPIA CO., LTD. | BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:30

Label at a glance#

ProductRosatra Synergy for treatment of Acne Rosacea
Active ingredientEUCALYPTOL
Label structure6 sections

Label contents#

Full prescribing information#

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • For external use only.
  • Stop use and ask doctor if rash occurs.
  • Keep out reach of children.

Warning

WARNINGS SECTION

Keep out reach of children.

Other Information

SAFE HANDLING WARNING SECTION

Protect this product from excessive heat and direct sun.

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Eucalyptol 0.7g

For the treatment of Acne Rosacea, helps to relieve the symptoms of facial redness, dilated blood vessels.

OTC - PURPOSE SECTION

DOSAGE & ADMINISTRATION SECTION

Dosage and Usage

Adults 5ml maximum per day

Children 1ml maximum per day

Apply on skin and gentle massage around affected areas.

INDICATIONS & USAGE SECTION

INACTIVE INGREDIENT SECTION

Other Ingredients

Calendula Officinalis Seed Oil, Almond Oil, Evening Primrose Oil, Olive Oil, Carrot Seed Oil, Chamomile Flower Oil, Helichrysum Italicum Flower Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10011001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70470-1001-52021-01-29C16284748780-1ba0f9c33-5495-a910-e053-dadaa90a0b853f9f6bd4-58bf-4b49-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70470-1001-5Rosatra Synergyfor treatment of Acne Rosacea50 g in 1 BOTTLE, GLASSOIL502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70470-1001ROSATRA SYNERGY FOR TREATMENT OF ACNE ROSACEA (ROSATRA) OIL [PHYTOPIA CO., LTD.]2Legacy NDC, 1 package rows20191231_3f9f6bd4-58bf-4b49-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70470-100170470-1001-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELICHRYSUM ITALICUM FLOWER OILO97ZV7726KIACT
TAMANU OILJT3LVK84A1IACT
CALENDULA OFFICINALIS SEED OIL9JS8DS42SVIACT
ALMOND OIL66YXD4DKO9IACT
EUCALYPTOLRV6J6604TKACTIB
OLIVE OIL6UYK2W1W1EIACT
CARROT SEED OIL595AO13F11IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT

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
9afb31dd-1af2-3454-e053-2a95a90a9c2b3f9f6bd4-58bf-4b49-e054-00144ff88e882019-12-31WarningsExact identifier
spl id: 9afb31dd-1af2-3454-e053-2a95a90a9c2b
spl set id: 3f9f6bd4-58bf-4b49-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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