Tanac Oral Pain Reliever

Tanac Oral Pain Reliever
SPL v4
SPL
SPL Set ID 81cc61fa-31a7-2214-e053-2a91aa0ae46a
Route
ORAL
Published
Effective Date 2019-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (10 g)
Inactive Ingredients
Saccharin Tannic Acid Peppermint Propylene Glycol Benzalkonium Chloride Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-01

Description

Active Ingredient Purpose Benzocaine 10%........................................................ Oral pain reliever


Medication Information

Warnings and Precautions

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
Description

Active Ingredient Purpose Benzocaine 10%........................................................ Oral pain reliever

Uses

Temporarily relieves pain due to

  • canker sores
  • cold sores
  • fever blisters
  • minor irritations or injury of the mouth and gums
Section 55105-1
Active Ingredient Purpose
Benzocaine 10%........................................................ Oral pain reliever

Warnings

For oral use only.

Directions
  • apply product with cotton swab or clean fingertip to the affected area
  • adults and children 2 years of age and older: use up times 4 times daily or as directed by a

dentist or doctor. Children should be supervised in the use of this product.

  • children under 2 years of age: do not use
Do Not Use
  • for teething
  • in children under 2 years of age
Questions?

1-855-452-9500 or email at [email protected]

Other Information
  • store at 20 - 25°C (68 - 77°F)
  • do not use if imprinted safety seal is torn, broken or missing prior to opening
  • keep carton for full drug facts
Inactive Ingredients

benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid

Principal Display Panel
  • canker sores
  • gum irritations
  • cold sores
  • fever blisters

Tanac ®

Benzocaine 10%

Oral Pain Reliever

NO STING LIQUID

0.45 FL Oz. (13.3mL)

When Using This Product
  • avoid contact with the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed by a dentist or doctor
If Pregnant Or Breast Feeding,

ask a health professional before use.

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 Doctor Or Dentist If
  • sore mouth symptoms do not improve in 7 days
  • symptoms clear up and occur again within a few days
  • irritation, pain or redness persists or worsens swelling, rash, or fever develops

Structured Label Content

Uses

Temporarily relieves pain due to

  • canker sores
  • cold sores
  • fever blisters
  • minor irritations or injury of the mouth and gums
Warnings and Precautions (34071-1)

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
Section 55105-1 (55105-1)
Active Ingredient Purpose
Benzocaine 10%........................................................ Oral pain reliever

Warnings

For oral use only.

Directions
  • apply product with cotton swab or clean fingertip to the affected area
  • adults and children 2 years of age and older: use up times 4 times daily or as directed by a

dentist or doctor. Children should be supervised in the use of this product.

  • children under 2 years of age: do not use
Do Not Use (Do not use)
  • for teething
  • in children under 2 years of age
Questions?

1-855-452-9500 or email at [email protected]

Other Information (Other information)
  • store at 20 - 25°C (68 - 77°F)
  • do not use if imprinted safety seal is torn, broken or missing prior to opening
  • keep carton for full drug facts
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid

Principal Display Panel
  • canker sores
  • gum irritations
  • cold sores
  • fever blisters

Tanac ®

Benzocaine 10%

Oral Pain Reliever

NO STING LIQUID

0.45 FL Oz. (13.3mL)

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed by a dentist or doctor
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 Doctor Or Dentist If (Stop use and ask a doctor or dentist if)
  • sore mouth symptoms do not improve in 7 days
  • symptoms clear up and occur again within a few days
  • irritation, pain or redness persists or worsens swelling, rash, or fever develops

Advanced Ingredient Data


Raw Label Data

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