SLEEP DISORDER SYNERGY- sleep disorder synergy 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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Drug Facts

menthol(2.6%)

Balsam Peru Oil (2.4%)

Analgesic in the treatment of muscle pain

Use

Helps relieve the condition of pain and stiffness.

Dosage Suggestion

Adults 5ml maximum per day

Children 1ml maximum per day

Directions

Apply on skin and gentle massage around painful area.

Inactive Ingredients

EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL, JOJOBA OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER OIL

Warnings

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

Other Information

Protect this product from excessive heat

and direct sun.

Warnings

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

PainAway-With natural Peppermint and Balsam Peru Oil

PainAway

SLEEP DISORDER SYNERGY 
sleep disorder synergy oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL1.2 mg  in 50 mg
Inactive Ingredients
Ingredient NameStrength
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
JOJOBA OIL (UNII: 724GKU717M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SWEET MARJORAM OIL (UNII: ICH7BE016E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
Product Characteristics
Colorpurple (Violet Miron Bottle) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70470-1221-550 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34704/01/2016
Labeler - PHYTOPIA CO., LTD. (656940504)
Registrant - PHYTOPIA CO., LTD. (656940504)
Establishment
NameAddressID/FEIBusiness Operations
Phytopia Co., Ltd.656940504manufacture(70470-1221)

Revised: 1/2018
Document Id: 70a3e978-3a56-0bb3-e053-2a91aa0a62fe
Set id: 70a3c24c-4fa7-9a9d-e053-2a91aa0a9b60
Version: 1
Effective Time: 20180110
 
PHYTOPIA CO., LTD.