Drug Facts

Drug Facts
SPL v33033
SPL
SPL Set ID aa61ce6f-8336-4071-93b8-549fd22d1ae0
Route
TOPICAL
Published
Effective Date 2026-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g) Benzocaine (20 g) Menthol (0.26 g) Zinc Cation (0.15 g)
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-25

Description

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


Medication Information

Purpose

Benzalkonium Chloride     Oral Antibacterial 

Benzocaine       Oral Antibacterial     

Menthol      Oral Antibacterial

Zinc Chloride      Oral Antibacterial

Description

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

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.
Section 51945-4

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.

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
  • 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.
Drug Facts

Manufactured By

Zhejiang Jingwei Pharmaceutical Co., Ltd

Changshan Industrial Park, Zhejiang, China

Product of China

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.
Active Ingredients

Benzalkonium Chloride    0.13%

Benzocaine      20%

Menthol      0.26%

Zinc Chloride       0.15%

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

Imported and Distributed By

KUNGPO HEALTH CARE & HERBAL CENTER INC.

9320 Baseline Rd., Ste. L,

Rancho Cucamonga, CA 91701

Phone: 909-377-6878

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.


Structured Label Content

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.
Section 51945-4 (51945-4)

Purpose

Benzalkonium Chloride     Oral Antibacterial 

Benzocaine       Oral Antibacterial     

Menthol      Oral Antibacterial

Zinc Chloride      Oral Antibacterial

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.

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 (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.
Drug Facts

Manufactured By (Manufactured by)

Zhejiang Jingwei Pharmaceutical Co., Ltd

Changshan Industrial Park, Zhejiang, China

Product of China

Other Information (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.
Active Ingredients (Active ingredients)

Benzalkonium Chloride    0.13%

Benzocaine      20%

Menthol      0.26%

Zinc Chloride       0.15%

Inactive Ingredients (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

Imported and Distributed By (Imported and distributed by)

KUNGPO HEALTH CARE & HERBAL CENTER INC.

9320 Baseline Rd., Ste. L,

Rancho Cucamonga, CA 91701

Phone: 909-377-6878

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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