ROSATRA SYNERGY FOR TREATMENT OF ACNE ROSACEA- rosatra oil
PHYTOPIA CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

Drug Facts

Eucalyptol 0.7g

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

Dosage and Usage

Adults 5ml maximum per day

Children 1ml maximum per day

Apply on skin and gentle massage around affected areas.

Other Ingredients

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

1001

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - PHYTOPIA CO., LTD. (656940504)

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

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