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  5. Label Information: Red Cross Toothache

FDA Label for Red Cross Toothache

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DENTIST OR DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS

Red Cross Toothache 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



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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