ORA YOGU 4X MEDICATED TOOTH AND GUM PAIN RELIEVER- medicated tooth and gum pain reliever gel

Drug Labeling and Warnings

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORA YOGU 4X MEDICATED TOOTH AND GUM PAIN RELIEVER 
medicated tooth and gum pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87351-761
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.26 g  in 100 mL
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
CINNAMON (UNII: 5S29HWU6QB)
SALT SUBSTITUTE (UNII: HJT620308C)
SCHISANDRA CHINENSIS SEED (UNII: MO9DK65G18)
CYPERUS ROTUNDUS FRUIT (UNII: VD727WIZ56)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87351-761-10	1 in 1 PACKAGE	04/15/2026
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	04/15/2026

Labeler - Kungpo Health Care & Herbal Center Inc (118869850)

Registrant - Zhejiang Jingwei Pharmaceutical Co., Ltd (530876549)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd		530876549	manufacture(87351-761)