DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine liquid

Dentek Instant Pain Relief by

Drug Labeling and Warnings

Dentek Instant Pain Relief by is a Otc medication manufactured, distributed, or labeled by IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/10/2022

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

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