FDA Label for Oral Pain Relief
View Indications, Usage & Precautions
Oral Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Alaina Healthcare Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Drug Facts
Active ingredients Purpose |
Benzocaine 20%....................................................................Oral pain reliever |
Indications & Usage
Uses
- temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- canker sores
- minor dental procedures
- dentures
- sore gums
- braces
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 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
- for teething
- in children under 2 years of age
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.
Do not use:
Otc - Ask Doctor
When using this product:
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a doctor/dentist
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness lasts or worsens
- swelling, rash, or fever develops
Stop use and ask doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
adults and children 2 years of age and over | apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
children under 12 years of age | adult supervision should be given in the use of this product |
children under 2 years of age | do not use |
- For denture irritation:
- apply thin layer to the affected area
- do not reinsert dental work until irritation/pain is relieved
- rinse mouth well before reinserting
- store at 20-25°C (68-77°F)
- do not refrigerate
Other information
Inactive Ingredient
Inactive Ingredients
benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid
Package Label.Principal Display Panel
MAXIMUM STRENGTH
ORAL PAIN RELIEF GEL
FAST ACTING
Benzocaine 20% pain relieving gel
NET WT 0.5 OZ (14g)
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