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NDC 60630-0077-04 DenTek Instant Pain Relief 200 mg/mL Details

DenTek Instant Pain Relief 200 mg/mL

DenTek Instant Pain Relief is a DENTAL; TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by DenTek Oral Care, Inc.. The primary component is BENZOCAINE.

Product Information

NDC	60630-0077
Product ID	60630-077_bd751b9a-a6c1-47ca-8c3d-32d3ad657c2c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DenTek Instant Pain Relief
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	DENTAL; TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/mL
Substance Name	BENZOCAINE
Labeler Name	DenTek Oral Care, Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60630-0077-04 (60630007704)

Pricing Information	N/A
NDC Package Code	60630-077-04
Billing NDC	60630007704
Package	1 VIAL, GLASS in 1 CARTON (60630-077-04) / 3.5 mL in 1 VIAL, GLASS (60630-077-03)
Marketing Start Date	2015-07-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3a3468b4-0625-71cd-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	yellow (colorless to light yellow liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60630-077-04	1 in 1 CARTON	07/31/2015
1	NDC:60630-077-03	3.5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/31/2015

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