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Pain Relief by Safetec of America, Inc.

Dosage form: liquid
Ingredients: benzocaine 200mg in 1g
Labeler: Safetec of America, Inc.
NDC Code: 61010-8100

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

Active Ingredients

Benzocaine 20% (w/w)


Oral pain reliever


temporarily relieves pain caused by

  • toothache
  • dental work
  • minor irritation or injury of the mouth and gums
  • canker sores
  • cheek bites
  • gum sores
  • denture irritation


For oral use only. Avoid contact with eyes.

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 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 is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • 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 age 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, 15º to 30ºC (59º to 86ºF)
  • Avoid contact with eyes

Inactive ingredients

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Questions or Comments? 1-800-456-7077

Manufactured by
Buffalo, NY 14215. 800-456-7077

Principal Display Panel – 0.75 gram, 144 Packets Box Label

NDC 61010-8100-1


First Aid

Oral Pain Relief

Fast mouth sore relief for:

  • Canker Sores
  • Gum Pain
  • Toothache
  • Dental Work

Reorder No. 53117
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969

Principal Display Panel – 0.5 gram Packet


Oral Pain
0.5 g (1/57 oz.)

Safetec of America, Inc.
Buffalo, NY 14215

benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8100
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 
#Item CodePackage Description
1NDC:61010-8100-20.5 g in 1 PACKET
2NDC:61010-8100-1144 PACKET (144 PACKET) in 1 BOX
20.75 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2010
Labeler - Safetec of America, Inc. (874965262)
Safetec Of America, Inc.874965262MANUFACTURE(61010-8100)

Safetec of America, Inc.

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Medically reviewed on May 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.