Red Cross Canker Sore Ointment
FDA Label NDC 10742-8915

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Red Cross Canker Sore (NDC 10742-8915). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic/analgesic

Uses

temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

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 last more than 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

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

  • snip off tip of tube
  • apply to affected area; carefully coat with a protective layer
  • supervise children using this product
  • adults and children 2 years and over: use up to 4 times daily or as directed by a doctor
  • children under 2 years: ask a doctor

Inactive Ingredients

aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum

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