Skip to Content

← See all Pain Relief brands

Pain Relief by Safetec of America, Inc.

Medically reviewed on May 10, 2018

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)

Purpose

Oral pain reliever

Uses

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

Warnings

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.

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 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
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215. 800-456-7077

www.safetec.com

Principal Display Panel – 0.75 gram, 144 Packets Box Label

NDC 61010-8100-1

Safetec

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
Online: www.safetec.com

Principal Display Panel – 0.5 gram Packet

Safetec

Oral Pain
Relief
0.5 g (1/57 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

PAIN RELIEF 
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 
Packaging
#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)
Establishment
NameAddressID/FEIOperations
Safetec Of America, Inc.874965262MANUFACTURE(61010-8100)

 
Safetec of America, Inc.

← See all Pain Relief brands

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.

Hide