GURUNANDA ORAL PAIN RELIEF- menthol rinse

GuruNanda Oral Pain Relief by

Drug Labeling and Warnings

GuruNanda Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by GURUNANDA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 1.5%

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, Copaiba Balsam (Copaifera officinalis) Oil, Myrrh ( Commiphora myrrha) Oil, Tea Tree ( Melaleuca alternifolia) Oil, Thyme ( Thymus zygis) Oil, White Tumeric (Curcuma zedoaria) Oil, D-Alpha-Tocopherol (Vitamin E), Miswak (Salvadora persica) Extract, Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7)

Principal Display Panel

INGREDIENTS AND APPEARANCE

GURUNANDA ORAL PAIN RELIEF 
menthol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70708-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ZANTHOXYLUM ARMATUM FRUIT (UNII: ER3FV125H7)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
MYRRH OIL (UNII: H74221J5J4)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
CLOVE OIL (UNII: 578389D6D0)
SPEARMINT OIL (UNII: C3M81465G5)
MENAQUINONE-7 (UNII: 8427BML8NY)
SALVADORA PERSICA WHOLE (UNII: QY11DDA752)
COPAIFERA OFFICINALIS (BALSAM COPAIBA) RESIN (UNII: 1VH544O5AT)
CURCUMA ZEDOARIA OIL (UNII: QPP5U30FSD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70708-011-08	1 in 1 CARTON	07/04/2025
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/04/2025

Labeler - GURUNANDA, LLC (079671169)