PAIN RELIEF- benzocaine liquid 
Safetec of America, Inc.

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61010-8100-1,-2, Pain Relief

Active Ingredients

Benzocaine 20% (w/w)

Purpose

Oral pain reliever

Uses

temporarily relieves pain caused by

Warnings

For oral use only.Avoid contact with eyes.

Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

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. If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • for teething
  • in children under 2 years of age

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.In case of overdose, 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

Questions or Comments?

1-800-456-7077

Principal Display Panel - Safetec Oral Pain Relief Carton Label

NDC 61010-800-1

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 - Safetec Oral Pain Relief Carton Label

Principal Display Panel - Safetec Oral Pain Relief Packet Label

Safetec

Oral Pain Relief

0.75 g (1/38 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - Safetec Oral Pain Relief Packet Label
PAIN RELIEF 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 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:61010-8100-20.5 g in 1 PACKET; Type 0: Not a Combination Product02/01/2019
2NDC:61010-8100-1144 in 1 BOX02/01/2019
20.75 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/01/2010
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec Of America, Inc.874965262manufacture(61010-8100)

Revised: 2/2024
Document Id: 11867852-2084-bc57-e063-6394a90a45da
Set id: de84e598-d047-4fae-b2ed-155a3788bc6f
Version: 4
Effective Time: 20240216
 
Safetec of America, Inc.