FDA Label for Dental Relief
View Indications, Usage & Precautions
Dental Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cintas First Aid & Safety. 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.
Other
Drug Facts
Dental Relief
Active Ingredients
Benzocaine 20% (w/w)
Purpose
Oral antiseptic
Uses
For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.
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.
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
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 Ingredients
PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid
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
Principal Display Panel – Pocket Card
Dental Relief
PROFESSIONAL STRENGTH
RELIEVES DENTAL PAIN
COMPARE TO ORAJEL
SEE DRUG FACTS CARD
FOR COMPLETE WARNINGS
560718
12/13
Xpect
First aid
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