Red Cross Toothache Liquid
FDA Label NDC 10742-0009

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 Toothache (NDC 10742-0009). 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 dentist or 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

Eugenol 85%

Purpose

Toothache relief agent

Uses

temporarily relieves throbbing, persistent toothache due to a cavity until a dentist can be seen

Warnings

For external use only

Allergy alert: do not use if you are allergic to eugenol (clove oil)

When Using This Product

  • use only in teeth with persistent, throbbing pain
  • avoid touching tissues other than tooth cavity. Contact with lips or mucous membranes can cause burning, swelling, or irritation.
  • DO NOT SWALLOW to avoid irritation
  • do not use for more than 7 days
  • do not exceed recommended dosage

Stop Use And Ask A Dentist Or Doctor If

  • irritation persists, inflammation develops, or if fever and infection develop

    • See a dentist as soon as possible whether or not the pain is relieved. Toothaches and open cavities indicate serious problems that need prompt attention by a dentist.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • rinse tooth with water to remove any food particles from the cavity
  • using tweezers, immerse cotton pellet in medication
  • to prevent dripping, squeeze gently between fingers to remove excess liquid
  • place pellet in tooth cavity for one minutewithout touching surrounding tissues, then remove
  • supervise children using this product

    • adults and children 12 years and over: use up to 4 times daily or as directed by a dentist or doctor

    children under 12 years: ask a dentist or doctor

Inactive Ingredients

sesame oil

Questions

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

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