Dental Relief
Dental Relief
0f40f775-797e-43cf-88c9-00eea666494f
HUMAN OTC DRUG LABEL
Sep 23, 2025
Cintas Corporation
DUNS: 056481716
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
benzocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 0.5 gram Packet
Dental Relief
Active ingredients: Benzocaine (20%), Compound benzoin tincture
USES: Temporarily relieves pain due to canker sores, minor irritation of
the mouth and gums caused by dentures or orthodontic appliances,
or minor mouth and gum injuries.
Do not use if packet is torn or broken
NET WT 0.5g
INDICATIONS & USAGE SECTION
Uses
For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Benzocaine 20% (w/w)
OTC - PURPOSE SECTION
Purpose
Oral antiseptic
WARNINGS SECTION
Warnings
For oral use only
Allergy alert
Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock.
When using this product
Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
Keep out of reach of children.
If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- Adults and children 2 years and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor
- Consult a dentist or doctor for use on children under 2 years of age
- Children under 12 years of should be supervised in the use of this product
SPL UNCLASSIFIED SECTION
Other information
- Do not use if packet is torn, cut or opened
- Store at room temperature, 15° to 30°C (59° to 86°F)
- Avoid contact with eyes
INACTIVE INGREDIENT SECTION
Inactive Ingredients
PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid