Drug Facts - Red Cross Oral Pain Relief

Drug Facts - Red Cross Oral Pain Relief
SPL v5
SPL
SPL Set ID cbd41429-f730-4577-9f06-ef1831cf62e1
Route
TOPICAL
Published
Effective Date 2018-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Polyethylene Glycol 400 Propylene Glycol Saccharin Calcium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-01

Description

Benzocaine 20%

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Benzocaine 20%

Uses

temporarily relieves pain associated with ▪ toothache ▪ canker sores ▪ minor mouth irritation or injury of the mouth and gums caused by dentures or braces

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

Directions
  • using tweezers, immerse cotton pellet in medication
  • apply pellet to affected area, then remove
  • adults and children 2 years and over: use up to 4 times daily or as directed by a dentist or doctor
  • children under 12 years: supervise while using this product
  • children under 2 years: do not use
Do Not Use
  • for teething
  • in children under 2 years of age
Active Ingredient

Benzocaine 20%

Inactive Ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, propylene glycol, saccharin calcium

Principal Display Panel

When Using This Product
  • do not use for more than 7 days unless directed by a dentist or doctor
  • do not exceed recommended dosage
Stop Use and Ask A Doctor If
  • sore mouth symptoms do not improve in 7 days
  • swelling, rash, or fever develops
  • irritation, pain, or redness persists or worsens
Keep Out of Reach of Children

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses

temporarily relieves pain associated with ▪ toothache ▪ canker sores ▪ minor mouth irritation or injury of the mouth and gums caused by dentures or braces

Purpose

Oral pain reliever

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

Directions
  • using tweezers, immerse cotton pellet in medication
  • apply pellet to affected area, then remove
  • adults and children 2 years and over: use up to 4 times daily or as directed by a dentist or doctor
  • children under 12 years: supervise while using this product
  • children under 2 years: do not use
Do Not Use
  • for teething
  • in children under 2 years of age
Active Ingredient (Active ingredient)

Benzocaine 20%

Inactive Ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, propylene glycol, saccharin calcium

Principal Display Panel

When Using This Product (When using this product)
  • do not use for more than 7 days unless directed by a dentist or doctor
  • do not exceed recommended dosage
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sore mouth symptoms do not improve in 7 days
  • swelling, rash, or fever develops
  • irritation, pain, or redness persists or worsens
Keep Out of Reach of Children

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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