FDA Label for Red Cross Oral Pain Relief

View Indications, Usage & Precautions

Red Cross Oral Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product The Mentholatum Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Benzocaine 20%


Purpose



Oral pain reliever


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



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



  • •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.


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: ask a dentist or doctor

Inactive Ingredients



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


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