Active ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

for the temporary relief of pain due to:

toothaches
canker sore
cold sores
sore gums

Warnings

Allergy Alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

When using this product

avoid contact with the eyes
do not exceed recommended dosage
do not use for more than 7 days unless than 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 right away.

Directions

dip applicator into liquid

Adults and children 2 years of age 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 under 12 years of age: Should be supervised in the use of this product.

Children under 2 years of age: Ask a dentist or doctor.

Other information

do not use if safety seal on carton is broken
this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
do not use continuously

Inactive ingredients

Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Questions or comments?

Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at info@DenTek.com

DenTek Instant Pain Relief Inner Vial Label

Entire Label

DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83062-410(NDC:60630-077)
Route of Administration	DENTAL

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
SUCRALOSE (UNII: 96K6UQ3ZD4)	10 mg in 1 mL
SPEARMINT OIL (UNII: C3M81465G5)	3.3 mg in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	784.5 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:83062-410-04	1 in 1 CARTON	10/10/2022
1	NDC:83062-410-03	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 Drug	M022	10/10/2022

Labeler - IIMED MEDICAL MEXICANA S. DE R.L. DE C.V (812894376)

Name	Address	ID/FEI	Business Operations
Establishment
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V		812894376	relabel(83062-410) , repack(83062-410)

IIMED Dentek Instant Pain Relief