DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine liquid 
DenTek Oral Care, Inc.

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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DENTEK INSTANT PAIN RELIEF

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to:

Warnings

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 medical attention if you or a child in your care develops:

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.

Do not use

  • for teething
  • in children under 2 years of age

When using this product

  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a dentist or doctor if 

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

dip applicator into liquid

Adults and children 2 years and olderApply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Children between 2 and 12 years Should be supervised in the use of this product.
Children under 2 years Do not use.

     

Other information

Inactive ingredients

Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose 

PRINCIPAL DISPLAY PANEL

DenTek 

INSTANT PAIN RELIEF

Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

PRINCIPAL DISPLAY PANEL

DenTek™ 
INSTANT PAIN RELIEF 
Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE
 PRINCIPAL DISPLAY PANEL

DenTek™ 
INSTANT PAIN RELIEF 
Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-077
Route of AdministrationDENTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH) 2.2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 784.5 mg  in 1 mL
SPEARMINT OIL (UNII: C3M81465G5) 3.3 mg  in 1 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 10 mg  in 1 mL
Product Characteristics
Coloryellow (colorless to light yellow liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60630-077-041 in 1 CARTON07/31/2015
1NDC:60630-077-033.5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/31/2015
Labeler - DenTek Oral Care, Inc. (153818646)
Registrant - DenTek Oral Care, Inc. (153818646)

Revised: 10/2021
Document Id: bd751b9a-a6c1-47ca-8c3d-32d3ad657c2c
Set id: 3a3468b4-0625-71cd-e054-00144ff8d46c
Version: 6
Effective Time: 20211018
 
DenTek Oral Care, Inc.