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 DenTek Oral Care. Inc., DenTek Oral Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Outer carton labeling

Benzocaine 20%

Oral Pain Reliever

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

Warnings

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.

When using this product   avoid contact with the eyes  do not exceed recommended dosage  do not use for more than 7 days unless directe

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  1-800-952-5080 M-F 8am - 5pm EST of visit our website www.dentek.com

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: 60630-077
Route of Administration	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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60630-077-02	1 in 1 CARTON
1	NDC: 60630-077-01	3.7 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	02/01/2014

Labeler - DenTek Oral Care. Inc. (153818646)

Registrant - DenTek Oral Care, Inc. (153818646)