KELOID HEALER SYNERGY FOR TREATMENT OF KELOIDS- keloid healer 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

KELOID HEALER SYNERGY  FOR TREATMENT OF KELOIDS
keloid healer oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL1.3 mg  in 50 mg
BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL1.2 mg  in 50 mg
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
ST. JOHN'S WORT (UNII: UFH8805FKA)  
NIAOULI OIL (UNII: D50IC2T8FU)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
Product Characteristics
Colorbrown (50ml per bottle) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70470-1020-5500 mg in 1 BOTTLE, GLASS; 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(70470-1020)

Revised: 10/2016
Document Id: 3fa1a19a-4a83-1fad-e054-00144ff88e88
Set id: 3fa1a19a-4a82-1fad-e054-00144ff88e88
Version: 1
Effective Time: 20161024
 
PHYTOPIA CO., LTD.