FDA Label for Orca Pain Reliever Putty With Menthol

View Indications, Usage & Precautions

Orca Pain Reliever Putty With Menthol Product Label

The following document was submitted to the FDA by the labeler of this product Orca Products, Llc. 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.

Drug Facts




Active Ingredient (Per 0.525G)



Menthol 8.4mg


Purpose



oral pain reliever


Use



  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings




Do Not Use



  • this product for more than 7 days unless directed by a dentist or doctor.

When Using This Product



  • do not exceed recommended dosage.

Stop Use And Ask A Doctor If



  • sore mouth symptoms do not improve in 7 days 
  • irritation, pain, or redness persists or worsens 
  • swelling, rash, or fever develops

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact Poison Control Center right away.


Directions



  • Adults and children 12 years of age and older: Allow product dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor
    • Children under 12 years of age: Consult a dentist or doctor.

Other Information



  • Do not use if inner disc/safety seal is broken, cut or torn.

Inactive Ingredients



Aloe vera, cardamom oil, chamomile, cinnamon oil, clove oil, glycerin, guaiacol, maltrodextrin, safflower oil, tea tree oil, xanthan gum, xylitol.


Questions?



1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)


* Please review the disclaimer below.