Tendinitica Synergy For Treatment of Tendinitis: Package Insert and Label Information

TENDINITICA SYNERGY FOR TREATMENT OF TENDINITIS- menthol 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
(click image for full-size original)

TENDINITICA SYNERGY FOR TREATMENT OF TENDINITIS
tendinitica oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70470-1139
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 1.3 mg in 50 mg
Inactive Ingredients
Ingredient Name Strength
MATRICARIA CHAMOMILLA FLOWERING TOP OIL
CLARY SAGE OIL
LAVENDER OIL
OLIVE OIL
SUNFLOWER OIL
JOJOBA OIL
ROSEMARY OIL
BERGAMOT OIL
Product Characteristics
Color brown (50ml per bottle) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70470-1139-5 500 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 part356 04/01/2016
Labeler — PHYTOPIA CO., LTD. (656940504)
Registrant — PHYTOPIA CO., LTD. (656940504)
Establishment
Name Address ID/FEI Operations
Phytopia Co., Ltd. 656940504 manufacture (70470-1139)

Revised: 04/2016 PHYTOPIA CO., LTD.

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