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 Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Benzocaine 20%

PURPOSE

Purpose

Oral Pain Reliever

INDICATIONS & USAGE

Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums

WARNINGS

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 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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

QUESTIONS

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

DenTek Instant Pain Relief Outer Carton Label

INGREDIENTS AND APPEARANCE

DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-410(NDC:60630-077)
Route of Administration	DENTAL, TOPICAL

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
SUCRALOSE (UNII: 96K6UQ3ZD4)	10 mg  in 1 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	2.2 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: 67659-410-04	1 in 1 CARTON	07/31/2015
1	NDC: 67659-410-03	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 not final	part356	06/20/2002

Labeler - Team Technologies, Inc (192339703)

Registrant - Team Technologies, Inc (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc		079527756	relabel(67659-410) , repack(67659-410)