Keloid Healer Synergy For Treatment of Keloids: Package Insert and Label Information

KELOID HEALER SYNERGY FOR TREATMENT OF KELOIDS- eucalyptol and balsam peru oil 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.

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
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KELOID HEALER SYNERGY FOR TREATMENT OF KELOIDS
keloid healer oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70470-1020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 1.3 mg in 50 mg
BALSAM PERU OIL (BALSAM PERU OIL) BALSAM PERU OIL 1.2 mg in 50 mg
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL
BERGAMOT OIL
EVENING PRIMROSE OIL
ST. JOHN’S WORT
NIAOULI OIL
ROSA CANINA FRUIT OIL
ROSEMARY OIL
EUCALYPTUS RADIATA LEAF OIL
Product Characteristics
Color brown (50ml per bottle) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70470-1020-5 500 mg in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 04/01/2016
Labeler — PHYTOPIA CO., LTD. (656940504)
Registrant — PHYTOPIA CO., LTD. (656940504)
Establishment
Name Address ID/FEI Operations
Phytopia Co., Ltd. 656940504 manufacture (70470-1020)

Revised: 10/2016 PHYTOPIA CO., LTD.

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