FDA Label for Orca Complete Menthol Pain Reliever
View Indications, Usage & Precautions
Orca Complete Menthol Pain Reliever 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
Menthol 2%
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 daysÂ
- irritation, pain, or redness persists or worsensÂ
- 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: Place 8-10 drops onto ORCA Foam or similar reabsorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in use of this product.
- Children under 12 years of age: Consult a dentist or doctor.
Other Information
- Do not use if tamperproof seal is not intact at time of first use.
Inactive Ingredients
Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.
Questions?
1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)
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