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  5. Label Information: Ora Yogu 4x Medicated Tooth And Gum Pain Reliever

FDA Label for Ora Yogu 4x Medicated Tooth And Gum Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNING
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. MANUFACTURED BY
    13. IMPORTED AND DISTRIBUTED BY

Ora Yogu 4x Medicated Tooth And Gum Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Kungpo Health Care & Herbal Center Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredients



Benzalkonium Chloride    0.13%
Benzocaine      20%
Menthol      0.26%
Zinc Chloride       0.15%


Purpose



Benzalkonium Chloride     Oral Antibacterial 
Benzocaine       Oral Antibacterial     
Menthol      Oral Antibacterial
Zinc Chloride      Oral Antibacterial


Uses



  • Temporarily relieves pain caused by minor oral and gum injuries.
  • First aid to help prevent infection from minor oral irritations.
  • Improves loose teeth and maintains dental health.

Warning



Use of this product may cause methemoglobinemia, a serious condition that requires immediate treatment because it reduces the oxygen-carrying capacity of the blood. This can happen even if you have used this product before.


Do Not Use



  • Do not use this product if you have a history of allergy to procaine, butacaine, benzocaine, or other "caine" class local anesthetics. 
  • Do not exceed the recommended dosage for more than 7 days unless directed by a dentist or doctor.

Stop Use And Ask A Doctor If



  • Stop use and seek immediate medical attention if you or child in your care develops:
  • Pale, gray, or blue colored skin (cyanosis)
  • Headache 
  • Rapid heart rate 
  • Shortness of breath
  • Dizziness or lightheadedness
  • Fatigue or lack of energy
  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain, or redness persists or worsens.

Keep Out Of Reach Of Children.



In case of overdose or allergic reaction, get medical help or contact a poison Control Center right away.


Directions



  • Adult and children 2 years of age and over - Apply to affected area up to 4 times daily or as directed by a dentist or doctor.
  • Children between 2 and 12 years of age - Ask a doctor before use. Should be supervised in using this product.
  • Children under 2 years of age - Do not use.

Other Information



  • This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.
  • Do not use if temper-evident tab is open before first use.

Inactive Ingredients



SCHISANDRA CHINENSIS SEED, CINNAMON, SALT SUBSTITUTE, CYPERUS ROTUNDUS FRUIT, ALLANTOIN, CARBOMER 940, DISODIUM EDTA-COPPER, POLYETHYLENE GLYCOL 1000, POLYSORBATE 60, PROPYLENE GLYCOL, PVP, SODIUM SACCHARIN, SORBIC ACID, STEARYL ALCOHOL, WATER


Manufactured By



Zhejiang Jingwei Pharmaceutical Co., Ltd
Changshan Industrial Park, Zhejiang, China
Product of China


Imported And Distributed By



KUNGPO HEALTH CARE & HERBAL CENTER INC.
9320 Baseline Rd., Ste. L，
Rancho Cucamonga, CA 91701
Phone: 909-377-6878


* Please review the disclaimer below.