Dental Relief

Dosage form: liquid
Ingredients: benzocaine 200mg in 1g
Labeler: Cintas First Aid & Safety
NDC Code: 68421-8100

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

DENTAL RELIEF 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-8100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzocaine (benzocaine) benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 400 
polyethylene glycol 3350 
peppermint oil 
saccharin sodium dihydrate 
sorbic acid 
Packaging
#Item CodePackage Description
1NDC:68421-8100-310 PACKET in 1 BAG
1NDC:68421-8100-20.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/13/2012
Labeler - Cintas First Aid & Safety (056481716)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec Of America, Inc.874965262MANUFACTURE(68421-8100)

Revised: 02/2014
 
Cintas First Aid & Safety

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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