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)