Orca Pain Reliever Putty With Menthol Paste
FDA Label NDC 82939-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Orca Products, Llc for the product Orca Pain Reliever Putty With Menthol (NDC 82939-001). 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 drug facts, active ingredient (per 0.525g), purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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?

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