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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/31/2015

Labeler - DenTek Oral Care, Inc. (153818646)

Registrant - DenTek Oral Care, Inc. (153818646)