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Drug Facts
MADE WITH PRIDE AND CARE FOR H-E-B®
SAN ANTONIO, TX 78204
Heb Mouth Sore Relief
FDA Label NDC 37808-312
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heb for the product Heb Mouth Sore Relief (NDC 37808-312). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - 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
Otc - Active Ingredient
Active ingredient
Benzalkonium chloride 0.02%
Benzocaine 20%
Zinc chloride 0.1%
Otc - Purpose
Purpose
Oral Antiseptic
Oral Pain Reliever
Oral Astringent
Indications & Usage
Uses
temporarily relieves of pain caused by:
- canker sores
- cold sores
- fever blisters
- minor irritation of the mouth and gums
- to help protect against infection in minor oral irritation
Warnings
Warnings
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 the 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
Otc - Do Not Use
Do not use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
- for teething
- in children under 2 years of age
Otc - Stop Use
Stop use and ask a doctor if
- swelling, rash, fever develops
- irritation, pain or redness persist or worsen
- sore mouth symptoms do not improve in 7 days
- allergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- cut open tip of tube on score mark
- adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor.
- children under 12 years of age should be supervised in the use of this product.
- children under 2 years of age: do not use
Inactive Ingredient
Inactive ingredients Allantoin,Carbomer, Edetate Disodium, Mentha Piperata (Peppermint Oil), Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol.
Otc - Questions
Questions or Comments? Call 1-877-777-2473
Package Label.Principal Display Panel
H-E-B
MOUTH SORE RELIEF
FAST-ACTING GEL
TRIPLE MEDICATED
ORAL PAIN RELIEVER/ANTISEPTIC/ASTRINGENT
NET WT 0.42 OZ (11.9 g)
* Please review the disclaimer below.
