FDA.reportPublic FDA data

GuruNanda Oral Pain Relief

Manufacturer
GURUNANDA, LLC
Effective date
2025-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:36:02

Label at a glance#

ProductGuruNanda Oral Pain Relief
Active ingredientLEVOMENTHOL
Label structure9 sections

Indications and 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

Dosage and administration

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: Cons...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%

OTC - PURPOSE SECTION

Oral Analgesic

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

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

When using this product

WARNINGS SECTION

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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0868708687

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70708-01370708-013-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SPEARMINT OILC3M81465G5IACT
THYME OIL2UK410MY6BIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
CHOLECALCIFEROL1C6V77QF41IACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
MYRRH OILH74221J5J4IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
CLOVE OIL578389D6D0IACT
MENAQUINONE-78427BML8NYIACT
LEVOMENTHOLBZ1R15MTK7ACTIB
TEA TREE OILVIF565UC2GIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b8f41aa-a0a5-711e-e063-6294a90a56b5390fb3a4-86da-d9d6-e063-6294a90abf752025-08-04WarningsExact identifier
spl set id: 390fb3a4-86da-d9d6-e063-6294a90abf75

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.