Ora Yogu 4x Medicated Tooth And Gum Pain Reliever Gel
FDA Label NDC 87351-761

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kungpo Health Care & Herbal Center Inc for the product Ora Yogu 4x Medicated Tooth And Gum Pain Reliever (NDC 87351-761). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warning, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.
  • Do not use if Amper-Evident Tab is open before first use.
  • Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

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

POLYETHYLENE GLYCOL 300, POLYETHYLENE GLYCOL 3000, SACCHARIN SODIUM, SORBIC ACID, CINNAMON, SALT SUBSTITUTE, SCHISANDRA CHINENSIS SEED, CYPERUS ROTUNDUS FRUIT

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.
1155 S. Milliken Ave, Suite H，
Ontario, CA 91761
Phone: 909-377-6878

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