DenTek Instant Pain Relief Maximum Strength

Dosage form: liquid
Ingredients: BENZOCAINE 200mg in 1mL
Labeler: DenTek Oral Care, Inc.
NDC code: 60630-077

Medically reviewed by Drugs.com. Last updated on Dec 25, 2023.

DENTEK INSTANT PAIN RELIEF

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to:

toothaches
canker sores
cold sores
sore gums

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:

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.

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 older	Apply 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

for toothaches, use only as a temporary remedy until a dentist can be seen
store at 20-25⁰C (68-77⁰F).

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

DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60630-077
Route of Administration	DENTAL, TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (BENZOCAINE)	BENZOCAINE	200 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL	2.2 mg in 1 mL
POLYETHYLENE GLYCOL 400	784.5 mg in 1 mL
SPEARMINT OIL	3.3 mg in 1 mL
SUCRALOSE	10 mg in 1 mL

Product Characteristics
Color	YELLOW (colorless to light yellow liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:60630-077-04	1 VIAL, GLASS in 1 CARTON
1	NDC:60630-077-03	3.5 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/31/2015

Labeler - DenTek Oral Care, Inc. (153818646)

Registrant - DenTek Oral Care, Inc. (153818646)

Document Id: ba522f6f-1260-4bbf-a34e-7b6129ead8f4

Set id: 3a3468b4-0625-71cd-e054-00144ff8d46c

Version: 4

Effective Time: 20190102

DenTek Oral Care, Inc.

Further information

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

Medical Disclaimer

Migraine 101