ROSATRA SYNERGY FOR TREATMENT OF ACNE ROSACEA- rosatra oil

Rosatra Synergy by

Drug Labeling and Warnings

Rosatra Synergy by is a Otc medication manufactured, distributed, or labeled by PHYTOPIA CO., LTD., BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.,  BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warning

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

Warning

Keep out reach of children.

Other Information

Protect this product from excessive heat and direct sun.

ACTIVE INGREDIENT

Drug Facts

Eucalyptol 0.7g

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

DOSAGE & ADMINISTRATION

Dosage and Usage

Adults 5ml maximum per day

Children 1ml maximum per day

Apply on skin and gentle massage around affected areas.

INACTIVE INGREDIENT

Other Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROSATRA SYNERGY  FOR TREATMENT OF ACNE ROSACEA
rosatra oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70470-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.7 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
TAMANU OIL (UNII: JT3LVK84A1)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
ALMOND OIL (UNII: 66YXD4DKO9)
OLIVE OIL (UNII: 6UYK2W1W1E)
CARROT SEED OIL (UNII: 595AO13F11)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)

Product Characteristics
Color	brown (50ml per bottle)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70470-1001-5	50 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/29/2016

Labeler - PHYTOPIA CO., LTD. (656940504)

Registrant - BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD. (656368622)

Establishment
Name	Address	ID/FEI	Business Operations
BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.		656368622	manufacture(70470-1001)