DENTAL RELIEF- benzocaine liquid 
Cintas First Aid & Safety

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.

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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

Other information

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 – 0.5 gram Packet

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

Principal Display Panel – Pocket Card
DENTAL RELIEF 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-8100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 400 (UNII: B697894SGQ)  
polyethylene glycol 3350 (UNII: G2M7P15E5P)  
peppermint oil (UNII: AV092KU4JH)  
saccharin sodium (UNII: SB8ZUX40TY)  
sorbic acid (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68421-8100-310 in 1 BAG05/06/2016
1NDC:68421-8100-20.5 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:68421-8100-4500 in 1 BOX05/06/2016
2NDC:68421-8100-20.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/06/2016
Labeler - Cintas First Aid & Safety (056481716)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec Of America, Inc.874965262MANUFACTURE(68421-8100)

Revised: 2/2014
Document Id: d33a6568-11e9-426b-8eb0-0cfd44ede2ff
Set id: d9068a54-6123-4715-b025-a5bdb4d5c702
Version: 4
Effective Time: 20140227
 
Cintas First Aid & Safety