DenTek Instant Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

DenTek Instant Pain Relief

DenTek Oral Care. Inc.
DenTek Oral Care, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DenTek Instant Pain Relief

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Outer carton labeling

Outer carton labeling

Active ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

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

inner vial label

DenTek Instant Pain Relief

Benzocaine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:60630-077
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
Sucralose

Product Characteristics

Color
yellow (colorless to light yellow liquid)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60630-077-01 3.7 in 1 VIAL, GLASS
2 NDC:60630-077-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2014-02-01


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