Active Ingredient
Benzocaine 20%
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Tidefresh Mouth Sore And Toothache (NDC 87786-001). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzocaine 20%
Oral anesthetic/analgesic
Temporarily relieves pain and minor irritation of the mouth and gums due to canker sores.
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before.
Stop use and seek immediate medical attention if you or a 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
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics
for teething
in children under 2 years of age
do not use for more than 7 days unless directed by a dentist or doctor and do not exceed recommended dosage.
if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Remove protective cap before use; prime pump by pressing several times prior to initial application.
Spray directly onto affected oral ulcer/sore area to form a thin protective coating.
Adult supervision required when product is used by children.
Adults and children 2 years of age and older: apply up to 4 times daily or as directed by a doctor/dentist.
Children under 2 years of age: Do not use
Water,Aloe Barbadensis Leaf Extract,Butylated Hydroxytoluene, Cetylpyridinium Chloride, Chamomilla Recutita (Matricaria) Flower Extract, Cocos Nucifera (Coconut) Oil, Commiphora Myrrha Resin, Dimethicone, Echinacea Purpurea Extract, Glyceryl Stearate, Menthol, Mineral Oil, Silica Dimethicone Silylate, Tocopherol (Vitamin E), White Petrolatum
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