Iimed Dentek Instant Pain Relief

Iimed Dentek Instant Pain Relief
SPL v2
SPL
SPL Set ID eab430c5-f8e4-1132-e053-2a95a90aee2d
Route
DENTAL
Published
Effective Date 2022-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (2.2 mg)
Inactive Ingredients
Peppermint Oil Sucralose Spearmint Oil Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

Benzocaine 20%

Purpose

Oral Pain Reliever


Medication Information

Purpose

Oral Pain Reliever

Description

Benzocaine 20%

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.

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.

Active Ingredient

Benzocaine 20%

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 [email protected]

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
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

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
Dentek Instant Pain Relief Inner Vial Label


Structured Label Content

Uses

for the temporary relief of pain due to:

  • toothaches
  • canker sore
  • cold sores
  • sore gums
Purpose

Oral Pain Reliever

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.

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.

Active Ingredient (Active ingredient)

Benzocaine 20%

Other 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 Ingredients (Inactive ingredients)

Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Questions Or Comments? (Questions or comments?)

Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at [email protected]

When Using This Product (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
Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Dentist Or Doctor If (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
Dentek Instant Pain Relief Inner Vial Label (DenTek Instant Pain Relief Inner Vial Label)


Advanced Ingredient Data


Raw Label Data

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