Otc - Active Ingredient
Menthol 1.5%
Gurunanda Oral Pain Relief Rinse
FDA Label NDC 70708-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gurunanda, Llc for the product Gurunanda Oral Pain Relief (NDC 70708-011). 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 otc - active ingredient, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral Analgesic
Uses
- For temporary pain relief due to minor irritation or injury of the mouth and gums resulting from:
- Dental procedures
- Orthodontic appliances
- Dentures
- Canker Sores
- Other minor irritations of the mouth and gums
Warnings
Warnings
Do Not Use
this product for more than 7 days unless directed by a dentist or doctor.
When Using This Product
use only as directed. Read and follow all directions and warnings on this label.
- Do not swallow
- Do not exceed recommended dosage.
Stop Use And Ask Doctor If
- irritation, pain or redness persists or worsens
- swelling, rash or fever devleops
- sore mouth symptoms do not improve in 7 days
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
Directions
Adults and children 6 years of age and older: Pour 10 mL into the measuring cup. Swish, gargle, push between teeth, or allow to remain in place for at least 2 minutes. Do not swallow. Spit out into a trash can. Use up to twice daily, or as directed by a dentist or doctor. Brush your teeth after use.
Children under 12 years of age: Should be supervised in the use of this product.
Children under 6 years of age: Consult a dentist or doctor
Other Information
- Do not use if pritned neck seal is broken or missing
- Store in a cool place, away from heat and direct sunlight
Inactive Ingredients
Caprylic/Capric/Lauric Triglyceride, Clove (Eugenia caryophyllus) Oil, Peppermint ( Mentha piperita) Oil, Spearmint (Mentha spicata) Oil, Winged Prickly Ash ( Zanthoxylum alatum)Oil, Myrrh (Commiphora myrrha) Oil, Tea Tree ( Melaleuca alternifolia) Oil, Thyme ( Thymus zygis) Oil, D-Alpha-Tocopherol (Vitamin E), Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7)
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